Techniques for deployment of a prosthetic valve

ABSTRACT

A method includes percutaneously advancing an implant to a native heart valve of a subject, the implant being housed in a compressed state within a delivery tool. Next, the method includes unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant. Subsequently, the longitudinally-proximal portion of the implant is unhoused. Subsequently, the longitudinally-distal portion of the implant is unhoused. By unhousing flanges of the implant, the flanges automatically expand. Upon the flanges expanding, a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction. Other applications are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation application of U.S. patentapplication Ser. No. 15/668,659, filed Aug. 3, 2017, entitled,“Techniques for deployment of a prosthetic valve,” which issued as U.S.Pat. No. 10,918,481 and which:

-   -   (1) is a Continuation-In-Part of PCT application IL2016/050125,        filed Feb. 3, 2016, entitled “Prosthetic valve with        axially-sliding frames,” which published as WO 2016/125160, and        which claims priority from U.S. Provisional Patent Application        62/112,343 to Hariton et al., filed Feb. 5, 2015, and entitled        “Prosthetic valve with axially-sliding frames”; and    -   (2) is a Continuation-In-Part of U.S. patent application Ser.        No. 15/541,783, entitled “Prosthetic valve with axially-sliding        frames,” which issued as U.S. Pat. No. 9,974,651, and which is        the US National Phase of PCT application IL2016/050125, filed        Feb. 3, 2016, entitled “Prosthetic valve with axially-sliding        frames,” which published as WO 2016/125160, and which claims        priority from U.S. Provisional Patent Application 62/112,343 to        Hariton et al., filed Feb. 5, 2015, and entitled “Prosthetic        valve with axially-sliding frames.”

All of the above applications are incorporated herein by reference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to valvereplacement. More specifically, some applications of the presentinvention relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some applications, an implant is provided having a tubular portion,an upstream support portion and one or more flanges. The implant ispercutaneously deliverable to a native heart valve in a compressedstate, and is expandable at the native valve. The implant and itsdelivery system facilitate causing the upstream support portion and theflanges to protrude radially outward from the tubular portion withoutexpanding the tubular portion. Expansion of the tubular portion bringsthe upstream support portion and the flanges closer together, forsecuring the implant at the native valve by sandwiching tissue of thenative valve between the upstream support portion and the flanges.

For some applications, a delivery tool is provided, including a deliverycapsule, disposed at a distal portion of the tool. The delivery capsuleincludes a proximal capsule-portion dimensioned to house a first part ofan implant, and a distal capsule-portion dimensioned to house a secondpart of the implant; and an extracorporeal control portion, disposed ata proximal portion of the tool, the control portion including one ormore controllers and one or more locks. The controllers are operativelycoupled to the proximal and distal capsule-portions such that theproximal and distal capsule-portions are movable with respect to theimplant via actuation of the controllers. The tool has sequential statesin which movement of the proximal and distal capsule-portions isvariously inhibited or facilitated. For some applications, in responseto a movement of a capsule-portion that is facilitated in a given state,the tool unlocks the subsequent state.

There is therefore provided, in accordance with an application of thepresent invention, apparatus including an implant and a delivery tool,the tool including:

a delivery capsule, disposed at a distal portion of the tool, thedelivery capsule including a proximal capsule-portion dimensioned tohouse a first part of the implant, and a distal capsule-portiondimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of thetool, the control portion including one or more controllers and one ormore locks, the controllers being operatively coupled to the proximaland distal capsule-portions such that the proximal and distalcapsule-portions are movable with respect to the implant via actuationof the controllers,

and the controllers and the locks are mechanically cooperative suchthat:

-   -   in a state A of the tool:        -   a first distal movement of the distal capsule-portion up to            a first distance distally with respect to the implant is            facilitated,        -   a second distal movement of the distal capsule-portion            further distally with respect to the implant is inhibited,            and        -   a proximal movement of the proximal capsule-portion            proximally with respect to the implant is facilitated; and    -   in a state B of the tool:        -   the second distal movement of the distal capsule-portion is            facilitated.

In an application, in the state A, a lock of the one or more locks islocked, and unlocking of the lock transitions the tool into the state B.

In an application, the lock is not unlockable until the distalcapsule-portion has been moved the first distance distally with respectto the implant.

In an application, the lock is not unlockable until the proximalcapsule-portion has been moved proximally with respect to the implant.

In an application:

the one or more controllers include a first controller and a secondcontroller, and

in the state A, actuation of the first controller causes the firstdistal movement of the distal capsule-portion, and actuation of thesecond controller causes the proximal movement of the proximalcapsule-portion.

In an application, in the state B, further actuation of the firstcontroller causes the second distal movement of the distalcapsule-portion.

In an application, the one or more controllers further include a thirdcontroller, and, in the state B, actuation of the third controllercauses the second distal movement of the distal capsule-portion.

In an application, the implant is for use at a native mitral valve of asubject, and:

the first part of the implant includes an upstream support portion,configured to be placed against an upstream surface of the native mitralvalve,

the second part of the implant includes a downstream end of the implant,and a plurality of flanges (i) disposed longitudinally between theupstream support portion and the downstream end, and (ii) configured toengage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distalmovement of the distal capsule-portion unhouses, from the distalcapsule-portion, the plurality of flanges, but not the downstream end ofthe implant.

In an application, the implant is housed by the delivery capsule suchthat the second distal movement of the distal capsule-portion unhouses,from the distal capsule-portion, the downstream end of the implant.

In an application, the implant is housed by the delivery capsule suchthat the proximal movement of the proximal capsule-portion unhouses,from the proximal capsule-portion, the upstream support portion.

In an application, the implant includes:

a valve frame that includes:

-   -   a tubular portion shaped to define a lumen therethrough, and    -   the upstream support portion, extending from an upstream end of        the tubular portion;

an outer frame that circumscribes the tubular portion, and includes theplurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portionwithin the lumen.

In an application, the second part of the implant includes at least partof the tubular portion.

There is further provided, in accordance with an application of thepresent invention, apparatus including an implant and a delivery tool,the tool including:

a delivery capsule, disposed at a distal portion of the tool, thedelivery capsule including a proximal capsule-portion dimensioned tohouse a first part of the implant, and a distal capsule-portiondimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of thetool, the control portion including one or more controllers and one ormore locks, the controllers being operatively coupled to the proximaland distal capsule-portions such that the proximal and distalcapsule-portions are movable with respect to the implant via actuationof the controllers, and the controllers and the locks are mechanicallycooperative such that:

-   -   in a first state of the tool:        -   a first distal movement of the distal capsule-portion up to            a first distance distally with respect to the implant is            facilitated,        -   a second distal movement of the distal capsule-portion            further distally with respect to the implant is inhibited,        -   a proximal movement of the proximal capsule-portion            proximally with respect to the implant is inhibited, and        -   responsively to movement of the distal capsule-portion            distally, the tool automatically unlocks a second state of            the tool;    -   in the second state of the tool:        -   the proximal movement of the proximal capsule-portion is            facilitated,        -   the second distal movement of the distal capsule-portion            remains inhibited, and        -   responsively to movement of the proximal capsule-portion            proximally, the tool automatically unlocks a third state of            the tool; and    -   in the third state of the tool:        -   the second distal movement of the distal capsule-portion is            facilitated.

In an application, the tool automatically unlocks the second stateresponsively to the distal capsule-portion having moved the firstdistance.

In an application:

the one or more locks include a first lock and a second lock,

the one or more controllers include a first controller and a secondcontroller,

in the first state of the tool, actuation of the first controller causesthe first distal movement of the distal capsule-portion,

the tool automatically unlocks the second state by automatically makingthe first lock unlockable,

in the second state of the tool, actuation of the second controllercauses the proximal movement of the proximal capsule-portion, and

the tool automatically unlocks the third state by automatically makingthe second lock unlockable.

In an application, in the third state of the tool, further actuation ofthe first controller causes the second distal movement of the distalcapsule-portion.

In an application, the one or more controllers further include a thirdcontroller, and, in the third state of the tool, actuation of the thirdcontroller causes the second distal movement of the distalcapsule-portion.

In an application, the implant is for use at a native mitral valve of asubject, and:

the first part of the implant includes an upstream support portion,configured to be placed against an upstream surface of the native mitralvalve,

the second part of the implant includes a downstream end of the implant,and a plurality of flanges (i) disposed longitudinally between theupstream support portion and the downstream end, and (ii) configured toengage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distalmovement of the distal capsule-portion unhouses, from the distalcapsule-portion, the plurality of flanges, but not the downstream end ofthe implant.

In an application, the implant is housed by the delivery capsule suchthat the second distal movement of the distal capsule-portion unhouses,from the distal capsule-portion, the downstream end of the implant.

In an application, the implant is housed by the delivery capsule suchthat the proximal movement of the proximal capsule-portion unhouses,from the proximal capsule-portion, the upstream support portion.

In an application, the implant includes:

a valve frame that includes:

-   -   a tubular portion shaped to define a lumen therethrough, and    -   the upstream support portion, extending from an upstream end of        the tubular portion;

an outer frame that circumscribes the tubular portion, and includes theplurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portionwithin the lumen.

In an application, the second part of the implant includes at least partof the tubular portion.

There is further provided, in accordance with an application of thepresent invention, a method, including:

percutaneously advancing an implant to a native heart valve of asubject, the implant housed in a compressed state within a deliverytool;

unhousing a longitudinally-intermediate portion of the implant, thelongitudinally-intermediate portion being longitudinally between alongitudinally-proximal portion of the implant and a longitudinallydistal portion of the implant;

subsequently, unhousing the longitudinally-proximal portion of theimplant; and

subsequently, unhousing the longitudinally-distal portion of theimplant.

In an application:

unhousing the longitudinally-intermediate portion of the implantincludes unhousing flanges of the implant such that the flangesautomatically expand;

unhousing the longitudinally-proximal portion of the implant includesunhousing an upstream support portion of the implant such that theupstream support portion automatically expands; and

unhousing the longitudinally-distal portion of the implant includesunhousing the longitudinally-distal portion of the implant such that thelongitudinally-distal portion of the implant automatically expands.

In an application, the longitudinally-distal portion includes a tubularportion within which a valve member is disposed, and unhousing thelongitudinally-distal portion of the implant includes unhousing thelongitudinally-distal portion of the implant such that the tubularportion expands to form a lumen and the valve member regulates one-wayflow of blood through the lumen.

In an application, unhousing the longitudinally-distal portion of theimplant includes facilitating expansion of the implant such that thetubular portion expands and the flanges become longitudinally closer tothe upstream support portion.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including:

-   -   a tubular portion that circumscribes a longitudinal axis of the        valve frame so as to define a lumen along the axis, the tubular        portion defining a plurality of valve-frame coupling elements        disposed circumferentially around the longitudinal axis; and    -   a plurality of arms, extending radially outward from an upstream        portion of the tubular portion to define an arm span, and        configured to engage tissue in the atrium;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen; and

an outer frame:

-   -   coupled to the valve frame, and    -   including a ring that circumscribes the tubular portion, and a        plurality of flanges that extend radially outward from the ring        to define a flange span, and are configured to engage tissue of        the ventricle,        and:

each arm of the plurality of arms defines a rigid portion and a flexibleportion that is disposed radially outward from the rigid portion, and ismore flexible than the rigid portion, and the majority of the flexibleportion is disposed further radially outward than the flange span.

In an application, the implant is configured such that the rigid portionprovides resistance against axial movement of the implant, while theflexible portion facilitates conformation of the arm to anatomy of theatrium and/or lateral movement of the implant within the native valve.

In an application, each arm of the plurality of arms defines aserpentine shape in the flexible portion.

In an application, each arm of the plurality of arms defines a pluralityof holes in the flexible portion.

In an application, less than 90 percent of the flexible portion isdisposed further radially outward than the flange span.

In an application, more than 60 percent of the flexible portion isdisposed further radially outward than the flange span.

In an application, for each arm of the plurality of arms, the flexibleportion covers an overall surface area including (i) the area occupiedby material from which the arm is formed, and (ii) spaces, and thematerial from which the arm is formed occupies less than 80 percent ofthe overall surface area.

In an application, the material from which the arm is formed occupiesmore than 20 percent of the overall surface area.

In an application, the material from which the arm is formed occupiesless than 70 percent of the overall surface area.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end, and the pattern of the ring having an amplitude        longitudinally between the peaks and the troughs,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to a        respective valve-frame coupling element,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the outer-frame coupling elements to the valve-framecoupling elements is such that compression of the tubular portion fromthe expanded state toward the compressed state such that the valve-framecoupling elements pull the outer-frame coupling elements radiallyinward: (i) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) increases the amplitude of the pattern of the ring.

In an application, the ring circumscribes the tubular portion.

In an application, the valve-frame coupling elements are disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend.

In an application, the upstream support portion includes one or morefabric pockets disposed circumferentially, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In an application, the apparatus further includes an upstream supportportion that includes a plurality of arms that extend radially from thetubular portion, and:

the upstream support portion has (i) a constrained-arm state, and (ii) areleased-arm state in which the arms extend radially outward from thetubular portion,

each leg has a tissue-engaging flange that has (i) a constrained-flangestate, and (ii) a released-flange state in which the flange extendsradially outward from the tubular portion, and

the apparatus has an intermediate state in which (i) the tubular portionis in its compressed state, (ii) the upstream support portion is in itsreleased-arm state, and (iii) the legs are in their released-flangestate.

In an application:

the apparatus includes an implant that includes the valve frame, theleaflets, and the outer frame, and

the apparatus further includes a tool:

-   -   including a delivery capsule dimensioned (i) to house and retain        the implant in a compressed state of the implant in which (a)        the tubular portion is in its compressed state, (b) the upstream        support portion is in its constrained-arm state, and (c) the        legs are in their constrained-flange state, and (ii) to be        advanced percutaneously to the heart of the subject while the        implant is housed and in its compressed state, and    -   operable from outside the subject to:        -   transition the implant from its compressed state into the            intermediate state while retaining the tubular portion in            its compressed state, and        -   subsequently, expand the tubular portion toward its expanded            state.

In an application, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state, and (ii)subsequently, releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state.

In an application, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state, and (ii) subsequently, releasing the legs into theirreleased-flange state, while retaining the tubular portion in itscompressed state.

In an application, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state moves the flangeslongitudinally away from the valve-frame coupling elements.

In an application, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state reduces the amplitude of thepattern of the ring and passes the flanges between the arms.

In an application, the upstream support portion further includes acovering that covers the arms to form an annular shape in thereleased-arm state, and, when the apparatus is in its intermediatestate, expansion of the tubular portion from its compressed state towardits expanded state presses the flanges onto the covering.

In an application, in the compressed state of the tubular portion, adownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

In an application, in the expanded state of the tubular portion, thedownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including an implant that includes:

a valve frame that includes a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end, a downstream end, alongitudinal length therebetween, and a diameter transverse to thelongitudinal axis;

a valve member, coupled to the tubular portion, disposed within thelumen, and arranged to provide unidirectional upstream-to-downstreamflow of blood through the lumen;

an upstream support portion, coupled to the tubular portion; and

an outer frame, coupled to the tubular portion, and including atissue-engaging flange,

and:

the implant has a first state and a second state,

in both the first state and the second state, (i) the upstream supportportion extends radially outward from the tubular portion, and (ii) thetissue-engaging flange extends radially outward from the tubularportion, and

the tubular portion, the upstream support portion, and the outer frameare arranged such that transitioning of the implant from the first statetoward the second state:

-   -   increases the diameter of the tubular portion by a        diameter-increase amount,    -   decreases the length of the tubular portion by a length-decrease        amount, and    -   moves the flange a longitudinal distance toward or        toward-and-beyond the upstream support portion, the distance        being greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 20 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 30 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion,and the outer frame are arranged such that the longitudinal distance ismore than 40 percent greater than the length-decrease amount.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis, and        -   the pattern of the ring having an amplitude longitudinally            between the peaks and the troughs; and    -   a plurality of legs, each of the legs coupled to the ring at a        respective trough,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the peaks to the respective sites of the tubular portionis such that compression of the tubular portion from the expanded statetoward the compressed state such that the respective sites of thetubular portion pull the peaks radially inward via radially-inwardtension on the coupling points: (i) reduces a circumferential distancebetween each of the coupling points and its adjacent coupling points,and (ii) increases the amplitude of the pattern of the ring.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the valve frame defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end, and the pattern of the ring having an amplitude        longitudinally between the peaks and the troughs,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to a        respective valve-frame coupling element,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the outer-frame coupling elements with respect to thevalve-frame coupling elements is such that compression of the tubularportion from the expanded state toward the compressed state (i) pullsthe outer-frame coupling elements radially inward via radially-inwardpulling of the valve-frame coupling elements on the outer-frame couplingelements, (ii) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (iii) increases the amplitude of the pattern of the ring,without increasing a radial gap between the valve frame and the ring bymore than 1.5 mm.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject, theapparatus including:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis;

a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis, and        -   the pattern of the ring having an amplitude longitudinally            between the peaks and the troughs; and    -   a plurality of legs, each of the legs coupled to the ring at a        respective trough,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

the fixation of the peaks to the respective sites of the tubular portionis such that compression of the tubular portion from the expanded statetoward the compressed state (i) pulls the peaks radially inward viaradially-inward pulling of the respective sites of the tubular portionon the peaks, (ii) reduces a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (iii)increases the amplitude of the pattern of the ring, without increasing aradial gap between the valve frame and the ring by more than 1.5 mm.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end, a downstream end, anddefining a plurality of valve-frame coupling elements disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood through the lumen;

an outer frame:

-   -   including a ring defined by a pattern of alternating peaks and        troughs, the peaks being longitudinally closer to the upstream        end than to the downstream end, and the troughs being        longitudinally closer to the downstream end than to the upstream        end,    -   including a plurality of legs, each of the legs coupled to the        ring at a respective trough, and    -   shaped to define a plurality of outer-frame coupling elements,        each of the outer-frame coupling elements (i) coupled to the        ring at a respective peak, and (ii) fixed with respect to a        respective valve-frame coupling element at a respective coupling        point,        and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

expansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) moves the plurality of legs in a longitudinallyupstream direction with respect to the tubular portion.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion having an upstream end and a downstream end;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood through the lumen;

an outer frame, including:

-   -   a ring defined by a pattern of alternating peaks and troughs:        -   the peaks being longitudinally closer than the troughs to            the upstream end,        -   the peaks being fixed to respective sites of the tubular            portion at respective coupling points disposed            circumferentially around the longitudinal axis between the            upstream end and the downstream end but not at the upstream            end nor the downstream end; and        -   a plurality of legs, each of the legs coupled to the ring at            a respective trough,            and:

the tubular portion has (i) a compressed state in which the tubularportion has a compressed diameter, and (ii) an expanded state in whichthe tubular portion has an expanded diameter that is greater than thecompressed diameter, and

expansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (ii) moves theplurality of legs in a longitudinally upstream direction with respect tothe tubular portion.

In an application, the outer frame is coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in whichthe tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion hasan expanded diameter that is greater than the compressed diameter, and

is configured such that increasing the diameter of the tubular portiontoward the expanded diameter causes longitudinal movement:

-   -   of the upstream support portion toward the coupling point, and    -   of the tissue-engaging flange away from the coupling point.

In an application:

the apparatus includes an implant that includes the frame assembly andthe valve member, and

the apparatus further includes a tool:

-   -   including a delivery capsule dimensioned (i) to house and retain        the implant in the compressed state, and (ii) to be advanced        percutaneously to the heart of the subject while the implant is        housed and in the compressed state, and    -   operable from outside the subject to facilitate an increase of        the diameter of the tubular portion from the compressed diameter        toward the expanded diameter such that the increase of the        diameter actuates longitudinal movement:        -   of the upstream support portion toward the coupling point,            and        -   of the tissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes longitudinal movement of the upstreamend of the tubular portion toward the coupling point.

In an application, the coupling point is disposed closer to thedownstream end of the frame assembly than are either the tissue-engagingflange or the upstream support portion.

In an application, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis.

In an application:

the expanded state of the frame assembly is a fully-expanded state ofthe frame assembly,

the leg is expandable into an expanded state of the leg, independentlyof increasing the diameter of the tubular portion, and

in the expanded state of the leg, the leg extends away from the centrallongitudinal axis.

In an application:

in the expanded state of the frame assembly, the leg extends away fromthe central longitudinal axis, and

in the compressed state of the frame assembly, the leg is generallyparallel with the central longitudinal axis.

In an application, the frame assembly is configured such that thelongitudinal movement of the tissue-engaging flange away from thecoupling point is a translational movement of the tissue-engaging flangethat does not include rotation of the tissue-engaging flange.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes 1-20 mm of longitudinal movement of thetissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state causes 1-20 mm of longitudinal movement of theupstream support portion toward the coupling point.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state reduces a distance between the upstreamsupport portion and the tissue-engaging flange by 5-30 mm.

In an application, the frame assembly is configured such that increasingthe diameter of the tubular portion by expanding the frame assemblytoward the expanded state moves the tissue-engaging flangelongitudinally past the upstream support portion.

In an application:

the tubular portion is defined by a plurality of cells of the valveframe, and

increasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state:

-   -   includes (i) increasing a width, orthogonal to the longitudinal        axis of the frame assembly, of each cell, and (ii) reducing a        height, parallel with the longitudinal axis of the frame        assembly, of each cell, and    -   causes longitudinal movement of the upstream support portion        toward the coupling point by reducing a height, parallel with        the longitudinal axis of the frame assembly, of the tubular        portion, by reducing the height of each cell.

In an application, the leg is disposed on an outside of the tubularportion.

In an application:

the at least one leg includes a plurality of legs,

the coupling point includes a plurality of coupling points, and

the frame assembly includes a leg frame that circumscribes the tubularportion, includes the plurality of legs, and is coupled to the valveframe at the plurality of coupling points, such that the plurality oflegs is distributed circumferentially around the tubular portion.

In an application, the plurality of coupling points is disposedcircumferentially around the frame assembly on a transverse plane thatis orthogonal to the longitudinal axis of the frame assembly.

In an application, the plurality of legs is coupled to the valve framevia a plurality of struts, each strut:

having a first end that is coupled to a leg of the plurality of legs,and a second end that is coupled to a coupling point of the plurality ofcoupling points,

in the compressed state of the frame assembly, being disposed at a firstangle in which the first end is disposed closer to the downstream end ofthe frame assembly than is the second end, and

being deflectable with respect to the coupling point of the plurality ofcoupling points, such that increasing the diameter of the tubularportion by expanding the frame assembly toward the expanded state causesthe strut to deflect to a second angle in which the first end isdisposed further from the downstream end of the frame assembly than isthe first end in the compressed state of the frame assembly.

In an application, the leg frame is structured such that each leg of theplurality of legs is coupled to two struts of the plurality of struts,and two struts of the plurality of struts are coupled to each couplingpoint of the plurality of coupling points.

In an application, the leg is coupled to the valve frame via a strut,the strut:

having a first end that is coupled to the leg, and a second end that iscoupled to the coupling point,

in the compressed state of the frame assembly, being disposed at a firstangle in which the first end is disposed closer to the downstream end ofthe frame assembly than is the second end, and

being deflectable with respect to the coupling point, such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes the strut to deflect to asecond angle in which the first end is disposed further from thedownstream end of the frame assembly than is the first end in thecompressed state of the frame assembly.

In an application, the at least one leg includes at least a first legand a second leg.

In an application, the first leg and the second leg are both coupled tothe valve frame at the coupling point.

In an application, the first leg is coupled to the coupling point via arespective first strut, and the second leg is coupled to the couplingpoint via a respective second strut.

In an application, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly:

the coupling point is disposed, circumferentially with respect to thetubular portion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to thetubular portion, between the coupling point and the first leg, and

the second strut is disposed, circumferentially with respect to thetubular portion, between the coupling point and the second leg.

In an application, the coupling point includes at least a first couplingpoint and a second coupling point.

In an application, the leg is coupled to the valve frame at the firstcoupling point and at the second coupling point.

In an application, the leg is coupled to the first coupling point via arespective first strut, and to the second coupling point via arespective second strut.

In an application, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly:

the leg is disposed, circumferentially with respect to the tubularportion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to thetubular portion, between the leg and the first coupling point, and

the second strut is disposed, circumferentially with respect to thetubular portion, between the leg and the second coupling point.

In an application, in the expanded state of the frame assembly, theupstream support portion extends radially outward from the tubularportion.

In an application:

the expanded state of the frame assembly is a fully-expanded state ofthe frame assembly,

the upstream support portion is expandable into an expanded state of theupstream support portion, independently of increasing the diameter ofthe tubular portion, and

in the expanded state of the upstream support portion, the upstreamsupport portion extends radially outward from the tubular portion.

In an application, in the compressed state of the frame assembly, theupstream support portion is generally tubular, collinear with thetubular portion, and disposed around the central longitudinal axis.

In an application, in the expanded state of the frame assembly, an innerregion of the upstream support portion extends radially outward from thetubular portion at a first angle with respect to the tubular portion,and an outer region of the upstream support portion extends, from theinner region of the upstream support portion, further radially outwardfrom the tubular portion at a second angle with respect to the tubularportion, the second angle being smaller than the first angle.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in whichthe tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion hasan expanded diameter that is greater than the compressed diameter, and

is configured such that reducing the diameter of the tubular portiontoward the compressed diameter causes longitudinal movement:

-   -   of the upstream support portion away from the coupling point,        and    -   of the tissue-engaging flange toward the coupling point.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, including:

-   -   a valve frame, including:        -   a tubular portion having an upstream end and a downstream            end, and shaped to define a lumen therebetween, and        -   an upstream support portion, extending from the upstream end            of the tubular portion; and    -   at least one leg, coupled to the valve frame at a coupling        point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitateone-way liquid flow through the lumen from the upstream end of thetubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart,

is intracorporeally expandable into an expanded state in which adiameter of the tubular portion is greater than in the compressed state,and

is configured such that increasing the diameter of the tubular portionby expanding the frame assembly toward the expanded state causeslongitudinal movement of the tissue-engaging flange away from thecoupling point.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve of a heart of asubject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and acentral longitudinal axis therebetween, and including:

-   -   an inner frame including an inner-frame tubular portion that        circumscribes the central longitudinal axis, has an upstream end        and a downstream end, and defines a channel therebetween, the        inner frame defining a plurality of inner-frame couplings        disposed circumferentially at a longitudinal location of the        inner frame,    -   an outer frame including an outer-frame tubular portion that        coaxially circumscribes at least a portion of the inner-frame        tubular portion, the outer frame defining a plurality of        outer-frame couplings disposed circumferentially at a        longitudinal location of the outer frame, and    -   a plurality of connectors, each connector connecting a        respective inner-frame coupling to a respective outer-frame        coupling;

a liner, disposed over at least part of the inner-frame tubular portion;and

a plurality of prosthetic leaflets, coupled to the inner-frame tubularportion and disposed within the channel,

and:

the frame assembly: (i) is compressible by a radially-compressive forceinto a compressed state in which the inner frame is in a compressedstate thereof and the outer frame is in a compressed state thereof, (ii)is configured, upon removal of the radially-compressive force, toautomatically expand into an expanded state thereof in which the innerframe is in an expanded state thereof and the outer frame is in anexpanded state thereof,

in the expanded state of the frame assembly, the prosthetic leaflets areconfigured to facilitate one-way fluid flow, in a downstream direction,through the channel, and

the connection of the inner-frame couplings to the respectiveouter-frame couplings is such that expansion of the frame assembly fromthe compressed state to the expanded state causes the inner-frametubular portion to slide longitudinally in a downstream direction withrespect to the outer-frame tubular portion.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a native valve disposedbetween an atrium and a ventricle of a heart of a subject, the apparatusincluding:

a tubular portion, having an upstream portion that includes an upstreamend, and a downstream portion that includes a downstream end, and shapedto define a lumen between the upstream portion and the downstreamportion;

a plurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood from the upstreamportion to the downstream portion;

an annular upstream support portion:

-   -   having an inner portion that extends radially outward from the        upstream portion, and    -   including one or more fabric pockets disposed circumferentially        around the inner portion, each pocket of the one or more pockets        having an opening that faces a downstream direction.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion,

at the inner portion of the upstream support portion, the covering isclosely-fitted between the radially-inner parts of the arms, and

at the outer portion of the upstream support portion, the pockets areformed by the covering being loosely-fitted between the radially-outerparts of the arms.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion, the radially-outer part beingmore flexible than the radially-inner part.

In an application:

the upstream support portion includes (i) a plurality of arms thatextend radially outward from the tubular portion, and (ii) a covering,disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of theupstream support portion, and (ii) a radially-outer part at the outerportion of the upstream support portion,

at the outer portion of the upstream support portion, the pockets areformed by each arm curving to form a hook shape.

In an application, each pocket is shaped and arranged to billow inresponse to perivalvular flow of blood in an upstream direction.

In an application, the apparatus is configured to be transluminallydelivered to the heart, and implanted at the native valve by expansionof the apparatus, such that the upstream support portion is disposed inthe atrium and the tubular portion extends from the upstream supportportion into the ventricle, and each pocket is shaped and arranged suchthat perivalvular flow of blood in an upstream direction presses thepocket against tissue of the atrium.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a plurality of prosthetic valve leaflets; and

a frame assembly, including:

-   -   a tubular portion defined by a repeating pattern of cells, the        tubular portion extending circumferentially around a        longitudinal axis so as to define a longitudinal lumen, the        prosthetic valve leaflets coupled to the inner frame and        disposed within the lumen;    -   an outer frame, including a plurality of legs, distributed        circumferentially around the tubular portion, each leg having a        tissue-engaging flange;    -   an upstream support portion that includes a plurality of arms        that extend radially outward from the tubular portion; and    -   a plurality of appendages, each having a first end that defines        a coupling element via which the tubular portion is coupled to        the outer frame, and a second end;        and the frame assembly defines a plurality of hubs, distributed        circumferentially around the longitudinal axis on a plane that        is transverse to the longitudinal axis, each hub defined by        convergence and connection of, (i) two adjacent cells of the        tubular portion, (ii) an arm of the plurality of arms, and (iii)        an appendage of the plurality of appendages.

In an application, each hub has six radiating spokes, two of the sixspokes being part of a first cell of the two adjacent cells, two of thesix spokes being part of a second cell of the two adjacent cells, one ofthe six spokes being the arm, and one of the six spokes being the secondend of the appendage.

In an application, the appendages are in-plane with the tubular portion.

In an application, the appendages are in-plane with the outer frame.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing to heart, an implant:

-   -   including a valve frame, a valve member disposed within a lumen        defined by the valve frame, and at least one leg, coupled to the        valve frame at a coupling point, and    -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween;

positioning the implant within the heart such that a tissue-engagingflange of the leg is disposed downstream of the valve, and thereaftercausing the flange to protrude radially outward from the axis;

subsequently, while an upstream support portion of the valve frame isdisposed upstream of the valve, causing the upstream support portion toprotrude radially outward from the axis, such that tissue of the valveis disposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream supportportion and the flange by reducing a distance between the upstreamsupport portion and the flange by causing longitudinal movement (i) ofthe upstream support portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing to heart, an implant:

-   -   including a valve frame, a valve member disposed within a lumen        defined by the valve frame, and at least one leg, coupled to the        valve frame at a coupling point, and    -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween;

positioning the implant within the heart such that an upstream supportportion of the valve frame is disposed upstream of the valve, andthereafter causing the upstream support portion to protrude radiallyoutward from the axis;

subsequently, while a tissue-engaging flange of the leg is disposeddownstream of the valve, causing the tissue-engaging flange to protruderadially outward from the axis, such that tissue of the valve isdisposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream supportportion and the flange by reducing a distance between the upstreamsupport portion and the flange by causing longitudinal movement (i) ofthe upstream support portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing an implant to the heart, the implant:

-   -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween, and    -   including a tubular portion, an upstream support portion, and a        plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engagingflanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

-   -   causing the upstream support portion to extend radially outward        from the axis so as to have a first support-portion span, and    -   causing the flanges to extend radially outward from the axis so        as to have a first flange span; and

subsequently, causing the upstream support portion and the flanges movetoward each other by at least 5 mm by increasing a diameter of thetubular portion such that:

-   -   the upstream support portion extends radially outward so as to        have a second support-portion span, the first support-portion        span being at least 40 percent as great as the second        support-portion span, and    -   the flanges extend radially outward so as to have a second        flange span, the first flange span being at least 30 percent as        great as the second flange span.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including:

percutaneously advancing an implant to the heart, the implant:

-   -   having an upstream end, a downstream end, and a central        longitudinal axis therebetween, and    -   including a tubular portion, an upstream support portion, and a        plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engagingflanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

-   -   causing the upstream support portion to extend radially outward        from the axis, and    -   causing the flanges to extend radially outward from the axis so        as to have a first flange span; and

subsequently, by increasing a diameter of the tubular portion:

-   -   causing the upstream support portion and the flanges move toward        each other by at least 5 mm,    -   causing the upstream support portion to move further radially        outward from the axis, and    -   causing each flange of the plurality of flanges to translate        radially outward so as to have a second flange span that is        greater than the first flange span.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-H are schematic illustrations of an implant for usewith a native valve of a heart of a subject, in accordance with someapplications of the invention;

FIGS. 3A-C are schematic illustrations that show structural changes in aframe assembly during transitioning of the assembly between itscompressed and expanded states, in accordance with some applications ofthe invention;

FIGS. 4A-F are schematic illustrations of implantation of the implant atthe native valve, in accordance with some applications of the invention;

FIG. 5 is a schematic illustration of a step in the implantation of theimplant, in accordance with some applications of the invention;

FIG. 6 is a schematic illustration of the implant, in accordance withsome applications of the invention;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies ofrespective implants, in accordance with some applications of theinvention; and

FIGS. 9A-C are schematic illustrations of an implant comprising a frameassembly, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-H, which are schematicillustrations of an implant 20 for use with a native valve of a heart ofa subject, in accordance with some applications of the invention.Implant 20 comprises a frame assembly 22 that has an upstream end 24, adownstream end 26, and a central longitudinal axis ax1 therebetween.Frame assembly 22 comprises a valve frame 30 that comprises a tubularportion 32 that has an upstream end 34 and a downstream end 36, and isshaped to define a lumen 38 through the tubular portion from theupstream end to the downstream end. Tubular portion 32 circumscribesaxis ax1, and thereby defines lumen 38 along the axis. Valve frame 30further comprises an upstream support portion 40, extending fromupstream end 34 of tubular portion 32. Frame assembly 22 furthercomprises at least one leg 50, coupled to valve frame 30 at (e.g., via)a coupling point 52, and having a tissue-engaging flange 54.

Typically, and as described hereinbelow, leg 50 is part of an outerframe (or “leg frame”) 60, and frames 30 and 60 define respectivecoupling elements 31 and 61, which are fixed with respect to each otherat coupling points 52. Typically, frames 30 and 60 are coupled to eachother only at coupling points 52 (e.g., only via the fixation ofcoupling elements 31 and 61 with respect to each other).

Implant 20 further comprises a valve member 58 (e.g., one or moreprosthetic leaflets) disposed within lumen 38, and configured tofacilitate one-way liquid flow through the lumen from upstream end 34 todownstream end 36 (e.g., thereby defining the orientation of theupstream and downstream ends of tubular portion 32). FIG. 1A showsimplant 20 in a fully-expanded state, in which frame assembly 22 is in afully-expanded state. FIG. 1B shows an exploded view of frame assembly22 in its fully-expanded state. FIGS. 2A-E show respective states ofimplant 20, which will be discussed in more detail hereinbelow withrespect to the implantation of the implant and the anatomy in which theimplant is implanted. FIG. 2A shows implant 20 in a compressed state (inwhich frame assembly 22 is in a compressed state), for percutaneousdelivery of the implant to the heart of the subject. Typically, in thecompressed state, leg 50 (including flange 54 thereof) is in aconstrained-flange state in which the flange is generally parallel withaxis ax1. Further typically, in the compressed state, upstream supportportion 40 is generally tubular, collinear with tubular portion 32(e.g., extending collinearly from the tubular portion), and disposedaround axis ax1.

FIG. 2B shows a state of implant 20 in which tissue-engaging flange 54of each leg 50 extends radially away from axis ax1 (e.g., radially awayfrom tubular portion 32). FIG. 2C shows a state of implant 20 in whichupstream-support portion 40 extends radially away from axis ax1 (andthereby radially away from tubular portion 32). FIG. 2D shows a state ofimplant 20 in which both flange 54 and portion 40 extend away from axisax1. In the fully-expanded state (FIGS. 1A-B) both upstream supportportion 40 and flange 54 extend radially away from axis ax1. Typically,frame assembly 22 is biased (e.g., shape-set) to assume itsfully-expanded state, which is shown in FIG. 2E. Transitioning ofimplant 20 between the respective states is typically controlled bydelivery apparatus, such as by constraining the implant in a compressedstate within a delivery tube and/or against a control rod, andselectively releasing portions of the implant to allow them to expand.

In the compressed state of frame assembly 22, tubular portion 32 has adiameter d1, and in the expanded state, the tubular portion has adiameter d2 that is greater that diameter d1. For some applications,diameter d1 is 4-15 mm, (e.g., 5-11 mm) and diameter d2 is 20-50 mm,(e.g., 23-33 mm). Frame assembly 22 is configured such that increasingthe diameter of tubular portion 32 (e.g., from d1 to d2) causeslongitudinal movement of flange 54 away from coupling point 52. In thesame way, reducing the diameter of tubular portion 32 (e.g., from d2 tod1) causes longitudinal movement of flange 54 toward coupling point 52.It is to be noted that the term “longitudinal movement” (including thespecification and the claims) means movement parallel with centrallongitudinal axis ax1. Therefore, longitudinal movement of flange 54away from coupling point 52 means increasing a distance, measuredparallel with longitudinal axis ax1, between flange 54 and couplingpoint 52. An example of such a configuration is described in more detailwith respect to FIG. 3A.

Thus, expansion of tubular portion 32 from its compressed state towardits expanded state (i) increases a circumferential distance between eachof coupling points 52 and its adjacent coupling points (e.g., betweeneach of outer-frame coupling elements 61 and its adjacent outer-framecoupling elements) (e.g., from d8 to d9), and (ii) moves legs 50 in alongitudinally upstream direction with respect to the tubular portion.

Typically, frame assembly 22 is configured such that increasing thediameter of tubular portion 32 also causes longitudinal movement ofupstream support portion 40 toward coupling point 52, e.g., as describedin more detail with respect to FIGS. 3B-C. Typically, frame assembly 22is configured such that increasing the diameter of tubular portion 32also causes longitudinal movement of upstream end 34 of tubular portion32 toward coupling point 52. In the same way, reducing the diameter oftubular portion 32 causes longitudinal movement of upstream end 34 awayfrom coupling point 52.

For some applications, upstream support portion 40 comprises a pluralityof arms 46 that each extends radially outward from tubular portion 32(e.g., from upstream end 34 of the tubular portion). Arms 46 aretypically flexible. For some such applications, arms 46 are coupled totubular portion 32 such that each arm may deflect independently ofadjacent arms during implantation (e.g., due to anatomical topography).

For some applications, upstream support portion 40 comprises a pluralityof barbs 48 that extend out of a downstream surface of the upstreamsupport portion. For example, each arm 46 may comprise one or more ofbarbs 48. Barbs 48 press into tissue upstream of the native valve (e.g.,into the valve annulus), thereby inhibiting downstream movement ofimplant 20 (in addition to inhibition of downstream movement provided bythe geometry of upstream support portion 40).

One or more surfaces of frame assembly 22 are covered with a covering23, which typically comprises a flexible sheet, such as a fabric, e.g.,comprising polyester. Typically, covering 23 covers at least part oftubular portion 32, typically lining an inner surface of the tubularportion, and thereby defining lumen 38.

Further typically, upstream support portion 40 is covered with covering23, e.g., extending between arms 46 to form an annular shape. It ishypothesized that this reduces a likelihood of paravalvular leakage. Forsuch applications, excess covering 23 may be provided between arms 46 ofupstream support portion 40, so as to facilitate their independentmovement. Although FIG. 1A shows covering 23 covering an upstream sideof upstream support portion 40, the covering typically additionally (oralternatively) covers the downstream side of the upstream supportportion. For example, covering 23 may extend over the tips of arms 46and down the outside of the arms, or a separate piece of covering may beprovided on the downstream side of the upstream support portion.

Alternatively, each arm 46 may be individually covered in a sleeve ofcovering 23, thereby facilitating independent movement of the arms.

For some applications, at least part of legs 50 (e.g., flanges thereof)is covered with covering 23.

Typically, frame assembly 22 comprises a plurality of legs 50 (e.g., twoor more legs, e.g., 2-16 legs, such as 4-12 legs, such as 6-12 legs),arranged circumferentially around valve frame 30 (e.g., around theoutside of tubular portion 32). Typically, frame assembly 22 comprises aplurality of coupling points 52 at which the legs are coupled to valveframe 30.

As described in more detail hereinbelow (e.g., with reference to FIG.3A), each leg 50 is typically coupled to a coupling point 52 via a strut70. For some applications, each leg 50 is coupled to a plurality of(e.g., two) coupling points 52 via a respective plurality of (e.g., two)struts 70. For some such applications, frame assembly 22 is arrangedsuch that, in the expanded state of the frame assembly, leg 50 isdisposed, circumferentially with respect to tubular portion 32, betweentwo struts, and each of the two struts are disposed, circumferentiallywith respect to the tubular portion, between the leg and a respectivecoupling point 52.

For some applications, a plurality of (e.g., two) legs are coupled toeach coupling point 52 via a respective plurality of (e.g., two) struts70. For some such applications, frame assembly 22 is arranged such that,in the expanded state of the frame assembly, coupling point 52 isdisposed, circumferentially with respect to tubular portion 32, betweentwo struts 70, and each of the two struts are disposed,circumferentially with respect to the tubular portion, between thecoupling point and a respective leg 50.

For some applications, frame assembly 22 comprises an outer frame (e.g.,a leg frame) 60 that circumscribes tubular portion 32, comprises (ordefines) the plurality of legs 50 and the plurality of struts 70, and iscoupled to valve frame 30 at the plurality of coupling points 52, suchthat the plurality of legs is distributed circumferentially around thetubular portion. For such applications, outer frame 60 comprises a ring66 that is defined by a pattern of alternating peaks 64 and troughs 62,and that typically circumscribes tubular portion 32. For example, thering may comprise struts 70, extending between the peaks and troughs.Peaks 64 are longitudinally closer to upstream end 34 of tubular portion32 than to downstream end 36, and troughs 62 are longitudinally closerto the downstream end than to the upstream end. (It is to be noted thatthroughout this patent application, including the specification and theclaims, the term “longitudinally” means with respect to longitudinalaxis ax1. For example, “longitudinally closer” means closer along axisax1 (whether positioned on axis ax1 or lateral to axis ax1), and“longitudinal movement” means a change in position along axis ax1 (whichmay be in additional to movement toward or away from axis ax1).)Therefore, peaks 64 are closer than troughs 62 to upstream end 34, andtroughs 62 are closer than peaks 64 to downstream end 36. Forapplications in which frame 60 comprises ring 66, each leg 50 is coupledto the ring (or defined by frame 60) at a respective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66having a generally zig-zag shape. However, the scope of the inventionincludes ring 66 having another shape that defines peaks and troughs,such as a serpentine or sinusoid shape.

For applications in which frame assembly 22 has a plurality of couplingpoints 52, the coupling points (and therefore coupling elements 31 and61) are disposed circumferentially around the frame assembly (e.g.,around axis ax1), typically on a transverse plane that is orthogonal toaxis ax1. This transverse plane is illustrated by the position ofsection A-A in FIG. 2B. Alternatively, coupling points 52 may bedisposed at different longitudinal heights of frame assembly 22, e.g.,such that different flanges 54 are positioned and/or moved differentlyto others.

Typically, coupling points 52 (and therefore coupling elements 31 and61) are disposed longitudinally between upstream end 24 and downstreamend 26 of frame assembly 22, but not at either of these ends. Furthertypically, coupling points 52 are disposed longitudinally betweenupstream end 34 and downstream end 36 of tubular portion 32, but not ateither of these ends. For example, the coupling points may be more than3 mm (e.g., 4-10 mm) both from end 34 and from end 36. It ishypothesized that this advantageously positions the coupling points at apart of tubular portion 32 that is more rigid than end 34 or end 36.

It is to be noted that leg 50 is typically expandable into its expandedstate (e.g., a released-flange state) such that flange 54 extends awayfrom axis ax1, independently of increasing the diameter of tubularportion 32 (e.g., as shown in FIGS. 2B & 2D). Similarly, upstreamsupport portion 40 is typically expandable into its expanded state(e.g., a released-arm state) such that it (e.g., arms 46 thereof)extends away from axis ax1, independently of increasing the diameter oftubular portion 32 (e.g., as shown in FIG. 2C & 2D). The state shown inFIG. 2D may be considered to be an intermediate state. Therefore,implant 20 is typically configured such that legs 50 (e.g., flanges 54thereof) and upstream support portion 40 are expandable such that theyboth extend away from axis ax1, while retaining a distance d3therebetween. This distance is subsequently reducible to a distance d4by expanding tubular portion 32 (e.g., shown in FIG. 2E).

For some applications, while tubular portion 32 remains in itscompressed state, flange 54 can extend away from axis ax1 over 40percent (e.g., 40-80 percent, such as 40-70 percent) of the distancethat it extends from the axis subsequent to the expansion of the tubularportion. For example, for applications in which implant 20 comprises aflange on opposing sides of the implant, a span d15 of the flanges whiletubular portion 32 is in its compressed state may be at least 40 percent(e.g., 40-80 percent, such as 40-70 percent) as great as a span d16 ofthe flanges subsequent to the expansion of the tubular portion. For someapplications, span d15 is greater than 15 mm and/or less than 50 mm(e.g., 20-30 mm). For some applications, span d16 is greater than 30 mmand/or less than 60 mm (e.g., 40-50 mm). It is to be noted that flange54 is effectively fully expanded, with respect to other portions of leg50 and/or with respect to tubular portion 32, before and after theexpansion of the tubular portion.

Similarly, for some applications, while tubular portion 32 remains inits compressed state, upstream support portion 40 (e.g., arms 46) canextend away from axis ax1 over 30 percent (e.g., 30-70 percent) of thedistance that it extends from the axis subsequent to the expansion ofthe tubular portion. That is, for some applications, a span d17 of theupstream support portion while tubular portion 32 is in its compressedstate may be at least 30 percent (e.g., 30-70 percent) as great as aspan d18 of the upstream support portion subsequent to the expansion ofthe tubular portion. For some applications, span d17 is greater than 16mm (e.g., greater than 20 mm) and/or less than 50 mm (e.g., 30-40 mm).For some applications, span d18 is greater than 40 mm and/or less than65 mm (e.g., 45-56 mm, such as 45-50 mm). It is to be noted thatupstream support portion 40 is effectively fully expanded, with respectto tubular portion 32, before and after the expansion of the tubularportion.

It is to be noted that when tubular portion 32 is expanded, flanges 54typically translate radially outward from span d15 to span d16 (e.g.,without deflecting). Typically, upstream support portion 40 behavessimilarly (e.g., arms 46 translated radially outward from span d17 tospan d18, e.g., without deflecting). That is, an orientation of eachflange 54 and/or each arm 46 with respect to tubular portion 32 and/oraxis ax1 is typically the same in the state shown in FIG. 2D as it is inthe state shown in FIG. 2E. Similarly, for some applications anorientation of each flange 54 with respect to upstream support portion40 (e.g., with respect to one or more arms 46 thereof) is the samebefore and after expansion of tubular portion 32.

For some applications, increasing the diameter of tubular portion 32from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g.,1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement of flange54 away from coupling point 52. For some applications, increasing thediameter of tubular portion 32 from d1 to d2 causes greater than 1 mmand/or less than 20 mm (e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) oflongitudinal movement of upstream support portion 40 toward couplingpoint 52. For some applications, distance d3 is 7-30 mm. For someapplications, distance d4 is 0-15 mm (e.g., 2-15 mm). For someapplications, increasing the diameter of tubular portion 32 from d1 tod2 reduces the distance between the upstream support portion and flanges54 by more than 5 mm and/or less than 30 mm, such as 5-30 mm (e.g.,10-30 mm, such as 10-20 mm or 20-30 mm). For some applications, thedifference between d3 and d4 is generally equal to the differencebetween d1 and d2. For some applications, the difference between d3 andd4 is more than 1.2 and/or less than 3 times (e.g., 1.5-2.5 times, suchas about 2 times) greater than the difference between d1 and d2.

For some applications, flanges 54 curve such that a tip of each flangeis disposed at a shallower angle with respect to inner region 42 ofupstream support portion 40, than are portions of leg 50 that are closerto downstream end 26 of frame assembly 22. For some such applications, atip of each flange may be generally parallel with inner region 42. Forsome such applications, while tubular portion 32 is in its expandedstate, a tip portion 55 of each flange 54 that extends from the tip ofthe flange at least 2 mm along the flange, is disposed within 2 mm ofupstream support portion 40. Thus, for some applications, while tubularportion 32 is in its expanded state, for at least 5 percent (e.g., 5-8percent, or at least 8 percent) of span 18 of upstream support portion40, the upstream support portion is disposed within 2 mm of a flange 54.

For some applications, in the absence of any obstruction (such as tissueof the valve or covering 23) between flange 54 and upstream supportportion 40, increasing the diameter of tubular portion 32 from d1 to d2causes the flange and the upstream support portion to move past eachother (e.g., the flange may move between arms 46 of the upstream supportportion), such that the flange is closer to the upstream end of implant20 than is the upstream support portion, e.g., as shown hereinbelow forframe assemblies 122 and 222, mutatis mutandis. (For applications inwhich upstream support portion 40 is covered by covering 23, flanges 54typically don't pass the covering. For example, in the absence of anyobstruction, flanges 54 may pass between arms 46, and press directlyagainst covering 23.) It is hypothesized that for some applications thisconfiguration applies greater force to the valve tissue beingsandwiched, and thereby further facilitates anchoring of the implant.That is, for some applications, distance d3 is smaller than the sum ofdistance d5 and a distance d14 (described with reference to FIG. 3C).For some applications, increasing the diameter of tubular portion 32from d1 to d2 advantageously causes flanges 54 and upstream supportportion 40 to move greater than 3 mm and/or less than 25 mm (e.g.,greater than 5 mm and/or less than 15 mm, e.g., 5-10 mm, such as about 7mm) with respect to each other (e.g., toward each other and then pasteach other).

For some applications, in the expanded state of frame assembly 22,upstream support portion 40 has an inner region (e.g., an inner ring) 42that extends radially outward at a first angle with respect to axis ax1(and typically with respect to tubular portion 32), and an outer region(e.g., an outer ring) 44 that extends, from the inner region, furtherradially outward from the tubular portion at a second angle with respectto the tubular portion, the second angle being smaller than the firstangle. For example, for some applications inner region 42 extendsradially outward at an angle alpha_1 of 60-120 degrees (e.g., 70-110degrees) with respect to axis ax1, and outer region 44 extends radiallyoutward at an angle alpha_2 of 5-70 degrees (e.g., 10-60 degrees) withrespect to axis ax1.

It is to be noted that angles alpha_1 and alpha_2 are measured betweenthe respective region support portion 40, and the portion of axis ax1that extends in an upstream direction from the level of frame assembly22 at which the respective region begins to extend radially outward.

For some applications in which implant 20 is configured to be placed atan atrioventricular valve (e.g., a mitral valve or a tricuspid valve) ofthe subject, region 42 is configured to be placed against the upstreamsurface of the annulus of the atrioventricular valve, and region 44 isconfigured to be placed against the walls of the atrium upstream of thevalve.

For some applications, each arm 46 defines a rigid portion 43 and aflexible portion 45 that is disposed radially outward from the rigidportion, and is more flexible than the rigid portion. Typically, atleast part of flexible portion 45 is disposed in outer region 44, and atleast part of rigid portion 43 is disposed in inner region 42.Therefore, typically overall, outer region 44 is more flexible thaninner region 42. To achieve this differential flexibility, each arm 46may have a different structure in portion 45 and/or region 44, than ithas in portion 43 and/or region 42.

FIG. 2G shows an arm 46 a, which is a variant of arm 46. Arm 46 adefines flexible portion 45 a, which is a variant of flexible portion45. In flexible portion 45 a, the material from which arm 46 a is formedis thinner than in rigid portion 43, but defines a serpentine or zig-zagpattern that increases the overall thickness of portion 45 a, and asshown, may make the overall thickness of portion 45 a equal to orgreater than the overall thickness of portion 43.

FIG. 2H shows an arm 46 b, which is a variant of arm 46. Arm 46 bdefines flexible portion 45 b, which is a variant of flexible portion45. In flexible portion 45 b, arm 46 b defines holes 47 in the materialfrom which arm 46 b is formed. Nonetheless, as shown, the overallthickness of portion 45 b may be equal to or greater than the overallthickness of portion 43.

Therefore, as shown for arms 46 a and 46 b, flexible portion 45 coversan overall surface area including (i) the area in which the materialfrom which the arm is formed occupies, and (ii) spaces, such as holes,or gaps between turns. For some applications, the material from whichthe arm is formed occupies less than 80 percent and/or more than 20percent of the overall surface area (e.g., 20-80 percent, e.g., 40-80percent, e.g., 40-70 percent of the overall surface area).

It is hypothesized that the relative rigidity of portion 43 and/orregion 42 provides resistance against axial movement (e.g., ventricularmigration) of implant 20, while the relative flexibility of portion 45and/or region 44 facilitates conformation of upstream support portion 40to the atrial anatomy and/or lateral movement of the implant within thenative valve.

For some applications, and as shown (e.g., in FIGS. 1A and 2E-F), in theexpanded state of frame assembly 22, the majority of flexible portion 45(e.g., more than 60 percent and/or less than 90 percent) is disposedfurther radially outward than span d16 of flanges 54.

For some applications, two or more of arms 46 are connected by aconnector (not shown), reducing the flexibility, and/or the independenceof movement of the connected arms relative to each other. For someapplications, arms 46 are connected in particular sectors of upstreamsupport portion 40, thereby making these sectors more rigid than sectorsin which the arms are not connected. For example, a relatively rigidsector may be provided to be placed against the posterior portion of themitral annulus, and a relatively flexible sector may be provided to beplaced against the anterior side of the mitral annulus, so as to reduceforces applied by upstream support portion 40 on the aortic sinus.

For some applications, and as shown, coupling points 52 are disposedcloser to downstream end 26 of frame assembly 22 than are flanges 54, oris upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement offlange 54 away from coupling point 52 (and the typical movement ofupstream support portion 40 toward the coupling point) facilitates thesandwiching of tissue of the native valve (e.g., leaflet and/or annulustissue) between the flange and the upstream support portion, therebysecuring implant 20 at the native valve.

Typically, in the compressed state of tubular portion 32, a downstreamend of each leg 50 is longitudinally closer than valve-frame couplingelements 31 to downstream end 36, and flange 54 of each leg is disposedlongitudinally closer than the valve-frame coupling elements to upstreamend 34. Typically, this is also the case in the expanded state oftubular portion 32.

FIGS. 3A-C show structural changes in frame assembly 22 duringtransitioning of the assembly between its compressed and expandedstates, in accordance with some applications of the invention. FIGS.3A-C each show a portion of the frame assembly, the structural changesthereof being representative of the structural changes that occur inother portions of the frame assembly. FIG. 3A shows a leg 50 and struts70 (e.g., a portion of outer frame 60), and illustrates the structuralchanges that occur around outer frame 60. FIG. 3B shows a portion ofvalve frame 30, and illustrates the structural changes that occur aroundthe valve frame. FIG. 3C shows valve frame 30 as a whole. In each ofFIGS. 3A-C, state (A) illustrates the structure while frame assembly 22(and in particular tubular portion 32) is in its compressed state, andstate (B) illustrates the structure while the frame assembly (and inparticular tubular portion 32) is in its expanded state.

FIG. 3A shows structural changes in the coupling of legs 50 to couplingpoint 52 (e.g., structural changes of outer frame 60) during thetransitioning of frame assembly 22 (and in particular tubular portion32) between its compressed and expanded states. Each leg 50 is coupledto valve frame 30 via at least one strut 70, which connects the leg tocoupling point 52. Typically, each leg 50 is coupled to valve frame 30via a plurality of struts 70. A first end 72 of each strut 70 is coupledto leg 50, and a second end 74 of each strut is coupled to a couplingpoint 52. As described hereinabove, for applications in which frame 60comprises ring 66, each leg 50 is coupled to the ring at a respectivetrough 62. Ring 66 may comprise struts 70, extending between the peaksand troughs, with each first end 72 at (or close to) a trough 62, andeach second end 74 at (or close to) a peak 64.

In the compressed state of frame assembly 22 (and in particular oftubular portion 32), each strut 70 is disposed at a first angle in whichfirst end 72 is disposed closer than second end 74 to the downstream endof the frame assembly. Expansion of frame assembly 22 (and in particularof tubular portion 32) toward its expanded state causes strut 70 todeflect to a second angle. This deflection moves first end 72 away fromthe downstream end of frame assembly 22. That is, in the expanded stateof frame assembly 22, first end 72 is further from the downstream end ofthe frame assembly than it is when the frame assembly is in itscompressed state. This movement is shown as a distance d5 between theposition of end 72 in state (A) and its position in state (B). Thismovement causes the above-described movement of flanges 54 away fromcoupling points 52. As shown, flanges 54 typically move the samedistance d5 in response to expansion of frame assembly 22.

For applications in which outer frame 60 comprises ring 66, the patternof alternating peaks and troughs may be described as having an amplitudelongitudinally between the peaks and troughs, i.e., measured parallelwith central longitudinal axis ax1 of frame assembly 22, and thetransition between the compressed and expanded states may be describedas follows: In the compressed state of frame assembly 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d20. In the expanded state frame assembly 22 (and inparticular of tubular portion 32), the pattern of ring 66 has anamplitude d21 that is lower than amplitude d20. Because (i) it is atpeaks 64 that ring 66 is coupled to valve frame 30 at coupling points52, and (ii) it is at troughs 62 that ring 66 is coupled to legs 50,this reduction in the amplitude of the pattern of ring 66 moves legs 50(e.g., flanges 54 thereof) longitudinally further from the downstreamend of the frame assembly. The magnitude of this longitudinal movement(e.g., the difference between magnitudes d20 and d21) is equal to d5.

Typically, distance d5 is the same distance as the distance that flange54 moves away from coupling point 52 during expansion of the frameassembly. That is, a distance between flange 54 and the portion of leg50 that is coupled to strut 70, typically remains constant duringexpansion of the frame assembly. For some applications, the longitudinalmovement of flange 54 away from coupling point 52 is a translationalmovement (e.g., a movement that does not include rotation or deflectionof the flange).

For some applications, a distance d6, measured parallel to axis ax1 offrame assembly 22, between coupling point 52 and first end 72 of strut70 while assembly 22 is in its compressed state, is 3-15 mm. For someapplications, a distance d7, measured parallel to axis ax1, betweencoupling point 52 and first end 72 of strut 70 while assembly 22 is inits expanded state, is 1-5 mm (e.g., 1-4 mm).

For some applications, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For someapplications, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some applications, and as shown, in the expanded state, first end 72of strut 70 is disposed closer to the downstream end of frame assembly22 than is coupling point 52. For some applications, in the expandedstate, first end 72 of strut 70 is disposed further from the downstreamend of frame assembly 22 than is coupling point 52.

For applications in which frame assembly 22 comprises a plurality oflegs 50 and a plurality of coupling points 52 (e.g., for applications inwhich the frame assembly comprises outer frame 60) expansion of theframe assembly increases a circumferential distance between adjacentcoupling points 52, and an increase in a circumferential distancebetween adjacent legs 50. FIG. 3A shows such an increase in thecircumferential distance between adjacent coupling points 52, from acircumferential distance d8 in the compressed state to a circumferentialdistance d9 in the expanded state. For some applications, distance d8 is1-6 mm. For some applications, distance d9 is 3-15 mm.

For some applications, in addition to being coupled via ring 66 (e.g.,struts 70 thereof) legs 50 are also connected to each other viaconnectors 78. Connectors 78 allow the described movement of legs 50during expansion of frame assembly 22, but typically stabilize legs 50relative to each other while the frame assembly is in its expandedstate. For example, connectors 78 may bend and/or deflect duringexpansion of the frame assembly.

FIGS. 3B-C show structural changes in valve frame 30 during thetransitioning of frame assembly 22 between its compressed and expandedstates. Tubular portion 32 of valve frame 30 is defined by a pluralityof cells 80, which are defined by the repeating pattern of the valveframe. When frame assembly 22 is expanded from its compressed statetoward its expanded state, cells 80 (i) widen from a width d10 to awidth d11 (measured orthogonal to axis ax1 of the frame assembly), and(ii) shorten from a height d12 to a height d13 (measured parallel toaxis ax1 of the frame assembly). This shortening reduces the overallheight (i.e., a longitudinal length between upstream end 34 anddownstream end 36) of tubular portion 32 from a height d22 to a heightd23, and thereby causes the above-described longitudinal movement ofupstream support portion 40 toward coupling points 52 by a distance d14(shown in FIG. 3C). For some applications, and as shown, coupling points52 are disposed at the widest part of each cell.

Due to the configurations described herein, the distance by whichflanges 54 move with respect to (e.g., toward, or toward-and-beyond)upstream support portion 40 (e.g., arms 46 thereof), is typicallygreater than the reduction in the overall height of tubular portion 32(e.g., more than 20 percent greater, such as more than 30 percentgreater, such as more than 40 percent greater). That is, implant 20comprises:

-   -   a valve frame (30) that comprises a tubular portion (32) that        circumscribes a longitudinal axis (ax1) of the valve frame so as        to define a lumen (38) along the axis, the tubular portion        having an upstream end (34), a downstream end (36), a        longitudinal length therebetween, and a diameter (e.g., d1 or        d2) transverse to the longitudinal axis;    -   a valve member (58), coupled to the tubular portion, disposed        within the lumen, and arranged to provide unidirectional        upstream-to-downstream flow of blood through the lumen;    -   an upstream support portion (40), coupled to the tubular        portion; and    -   an outer frame (60), coupled to the tubular portion, and        comprising a tissue-engaging flange (54),

wherein:

-   -   the implant has a first state (e.g., as shown in FIG. 2D and        FIG. 4D) and a second state (e.g., as shown in FIG. 2E and FIG.        4E),    -   in both the first state and the second state, (i) the upstream        support portion extends radially outward from the tubular        portion, and (ii) the tissue-engaging flange extends radially        outward from the tubular portion, and    -   the tubular portion, the upstream support portion, and the outer        frame are arranged such that transitioning of the implant from        the first state toward the second state:        -   increases the diameter of the tubular portion by a            diameter-increase amount (e.g., the difference between d1            and d2),        -   decreases the length of the tubular portion by a            length-decrease amount (e.g., the difference between d22 and            d23), and        -   moves the flange a longitudinal distance with respect to            (e.g., toward or toward-and-beyond) the upstream support            portion (e.g., the difference between d3 and d4), this            distance being greater than the length-decrease amount.

As shown in the figures, valve frame 30 is typically coupled to outerframe 60 by coupling between (i) a valve-frame coupling element 31defined by valve frame 30, and (ii) an outer-frame coupling element 61defined by outer frame 60 (e.g., an outer-frame coupling element iscoupled to end 74 of each strut). Typically, elements 31 and 61 arefixed with respect to each other. Each coupling point 52 is therebytypically defined as the point at which a valve-frame coupling elementand a corresponding outer-frame coupling element 61 are coupled (e.g.,are fixed with respect to each other). For some applications, and asshown, elements 31 and 61 are eyelets configured to be coupled togetherby a connector, such as a pin or suture. Alternatively or additionally,elements 31 and 61 are soldered or welded together. For example,elements 31 and 61 may be coupled together by a pin that passes throughthe eyelets, and is welded in place.

Typically, and as shown, valve-frame coupling elements 31 are defined bytubular portion 32, and are disposed circumferentially around centrallongitudinal axis ax1. Outer-frame coupling elements 61 are coupled toring 66 (or defined by frame 60, such as by ring 66) at respective peaks64.

As shown (e.g., in FIGS. 2A-E), valve frame 30 (e.g., tubular portion 32thereof) and outer frame 60 (e.g., ring 66 thereof) are arranged in aclose-fitting coaxial arrangement, in both the expanded and compressedstates of frame assembly 22. Ignoring spaces due to the cellularstructure of the frames, a radial gap d19 between valve frame 30 (e.g.,tubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)is typically less than 2 mm (e.g., less than 1 mm), in both thecompressed and expanded states, and during the transition therebetween.This is facilitated by the coupling between frames 30 and 60, and thebehavior, described hereinabove, of frame 60 in response to changes inthe diameter of tubular portion 32 (e.g., rather than solely due todelivery techniques and/or tools). For some applications, more than 50percent (e.g., more than 60 percent) of ring 66 is disposed within 2 mmof tubular portion 32 in both the compressed and expanded states, andduring the transition therebetween. For some applications, more than 50percent (e.g., more than 60 percent) of outer frame 60, except forflanges 54, is disposed within 2 mm of tubular portion 32 in both thecompressed and expanded states, and during the transition therebetween.

The structural changes to frame assembly 22 (e.g., to outer frame 60thereof) are described hereinabove as they occur during (e.g., as aresult of) expansion of the frame assembly (in particular tubularportion 32 thereof). This is the natural way to describe these changesbecause, as described hereinbelow with respect to FIGS. 4A-6 , assembly22 is in its compressed state during percutaneous delivery to theimplant site, and is subsequently expanded. However, the nature ofimplant 20 may be further understood by describing structural changesthat occur during compression of the frame assembly (e.g., a transitionfrom the expanded state in FIG. 2E to the intermediate state in FIG.2D), in particular tubular portion 32 thereof (including if tubularportion 32 were compressed by application of compressive force to thetubular portion, and not to frame 60 except via the tubular portionpulling frame 60 radially inward). Such descriptions may also berelevant because implant 20 is typically compressed (i.e., “crimped”)soon before its percutaneous delivery, and therefore these changes mayoccur while implant 20 is in the care of the operating physician.

For some applications, the fixation of peaks 64 to respective sites oftubular portion 32 is such that compression of the tubular portion fromits expanded state toward its compressed state such that the respectivesites of the tubular portion pull the peaks radially inward viaradially-inward tension on coupling points 52: (i) reduces acircumferential distance between each of the coupling points and itsadjacent coupling points (e.g., from d9 to d8), and (ii) increases theamplitude of the pattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of outer-frame coupling elements 61to valve-frame coupling elements 31 is such that compression of tubularportion 32 from its expanded state toward its compressed state such thatthe valve-frame coupling elements pull the outer-frame coupling elementsradially inward: (i) reduces a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements (e.g., from d9 to d8), and (ii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of peaks 64 to the respective sitesof tubular portion 32 is such that compression of the tubular portionfrom its expanded state toward its compressed state (i) pulls the peaksradially inward via radially-inward pulling of the respective sites ofthe tubular portion on the peaks, (ii) reduces a circumferentialdistance between each of coupling points 52 and its adjacent couplingpoints (e.g., from d9 to d8), and (iii) increases the amplitude of thepattern of ring 66 (e.g., from d21 to d20), without increasing radialgap d19 between valve frame 30 (e.g., tubular portion 32 thereof) andthe ring by more than 1.5 mm.

For some applications, the fixation of outer-frame coupling elements 61with respect to valve-frame coupling elements 31 is such thatcompression of tubular portion 32 from its expanded state toward itscompressed state (i) pulls outer-frame coupling elements 61 radiallyinward via radially-inward pulling of valve-frame coupling elements 31on outer-frame coupling elements 61, (ii) reduces a circumferentialdistance between each of the outer-frame coupling elements and itsadjacent outer-frame coupling elements (e.g., from d9 to d8), and (iii)increases the amplitude of the pattern of ring 66 (e.g., from d21 tod20), without increasing radial gap d19 between valve frame 30 (e.g.,tubular portion 32 thereof) and the ring by more than 1.5 mm.

Reference is made to FIGS. 4A-F, which are schematic illustrations ofimplantation of implant 20 at a native valve 10 of a heart 4 of asubject, in accordance with some applications of the invention. Valve 10is shown as a mitral valve of the subject, disposed between a leftatrium 6 and a left ventricle 8 of the subject. However, implant 20 maybe implanted at another heart valve of the subject, mutatis mutandis.Similarly, although FIGS. 4A-F show implant 20 being deliveredtransseptally via a sheath 88, the implant may alternatively bedelivered by any other suitable route, such as transatrially, ortransapically.

Implant 20 is delivered, in its compressed state, to native valve 10using a delivery tool 89 that is operable from outside the subject (FIG.4A). Typically, implant 20 is delivered within a delivery capsule 90 oftool 89, which retains the implant in its compressed state. Deliverycapsule 90 is disposed at a distal end of tool 89. A transseptalapproach, such as a transfemoral approach, is shown. Typically, implant20 is positioned such that at least flanges 54 are disposed downstreamof the native valve (i.e., within ventricle 8). At this stage, frameassembly 22 of implant 20 is as shown in FIG. 2A.

Subsequently, flanges 54 are allowed to protrude radially outward, asdescribed hereinabove, e.g., by releasing them from capsule 90 (FIG.4B). For example, and as shown, capsule 90 may comprise a distalcapsule-portion 92 and a proximal capsule-portion 94, and the distalcapsule-portion may be moved distally with respect to implant 20, so asto expose flanges 54. At this stage, frame assembly 22 of implant 20 isas shown in FIG. 2B.

Subsequently, implant 20 is moved upstream, such that upstream supportportion 40, in its compressed state, is disposed upstream of leaflets 12(i.e., within atrium 6). For some applications, the upstream movement ofimplant 20 causes flanges 54 to engage leaflets 12. However, because ofthe relatively large distance d3 provided by implant 20 (describedhereinabove), for some applications it is not necessary to move theimplant so far upstream that flanges 54 tightly engage leaflets 12and/or pull the leaflets upstream of the valve annulus. Upstream supportportion 40 is then allowed to expand such that it protrudes radiallyoutward, as described hereinabove, e.g., by releasing it from capsule 90(FIG. 4D). For example, and as shown, proximal capsule-portion 94 may bemoved proximally with respect to implant 20, so as to expose upstreamsupport portion 40. At this stage, frame assembly 22 of implant 20 is asshown in FIG. 2D, in which: (i) distance d3 exists between upstreamsupport portion 40 and flanges 54, (ii) the flanges have span d15, (iii)the upstream support portion has span d17, and (iv) tubular portion 32has diameter d1.

Typically, expansion of frame assembly 22 is inhibited by distalcapsule-portion 92, e.g., by inhibiting expansion of tubular portion 32.For example, a downstream region 33 of frame assembly 22, downstream offlanges 54, may remain compressed within distal capsule-portion 92.Alternatively or additionally, the expansion may be inhibited by anotherportion of delivery tool 89 (e.g., a portion of the delivery tool thatis disposed within lumen 38).

Subsequently, implant 20 is allowed to expand toward its expanded state,such that tubular portion 32 widens to diameter d2, and the distancebetween upstream support portion 40 and flanges 54 reduces to distanced4 (FIG. 4E). This is typically achieved by deploying downstream region33 from capsule-portion 92. This expansion sandwiches tissue of valve 10(typically including annular tissue and/or leaflets 12) between upstreamsupport portion 40 and flanges 54, thereby securing implant 20 at thevalve. FIG. 4F shows delivery capsule 90 having been removed from thebody of the subject, leaving implant 20 in place at valve 10.

As described hereinabove, implant 20 is configured such that whentubular portion 32 is expanded, flanges 54 and upstream support portion40 move a relatively large distance toward each other. This enablesdistance d3 to be relatively large, while distance d4 is sufficientlysmall to provide effective anchoring. As also described hereinabove,implant 20 is configured such that flanges 54 and upstream supportportion 40 can extend radially outward a relatively large distance whiletubular portion 32 remains compressed. It is hypothesized that for someapplications, these configurations (independently and/or together)facilitate effective anchoring of implant 20, by facilitating placementof a relatively large proportion of valve tissue (e.g., leaflets 12)between the flanges and the upstream support portion prior to expandingtubular portion 32 and sandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outwardextension of flanges 54 and upstream support portion 40 prior toexpansion of tubular portion 32, further facilitates theanchoring/sandwiching step by reducing radially-outward pushing of thevalve tissue (e.g., leaflets 12) during the expansion of the tubularportion, and thereby increasing the amount of valve tissue that issandwiched.

It is yet further hypothesized that this configuration of implant 20facilitates identifying correct positioning of the implant (i.e., withupstream support portion 40 upstream of leaflets 12 and flanges 54downstream of the leaflets) prior to expanding tubular portion 32 andsandwiching the valve tissue.

It is to be noted that the deployment of implant 20 is thereforeachieved by:

-   -   unhousing a longitudinally-intermediate portion of the implant        (to allow flanges 54 to expand), the longitudinally-intermediate        portion being longitudinally between a longitudinally-proximal        portion of the implant and a longitudinally distal portion of        the implant;    -   subsequently, unhousing the longitudinally-proximal portion of        the implant (to allow upstream support portion 40 to expand);        and    -   subsequently, unhousing the longitudinally-distal portion of the        implant (to allow the longitudinally-distal portion of the        implant, typically including the tubular portion within which        valve member 58 is disposed, to expand).

It is to be further noted that the deployment of implant 20 may bedescribed with respect to delivery tool 89. For example:

-   -   distal capsule-portion 92 is moved distally with respect to the        implant (to allow flanges 54 to expand);    -   subsequently, proximal capsule-portion 94 is moved proximally        with respect to the implant (to allow upstream support portion        40 to expand); and    -   subsequently, distal capsule-portion 92 is again moved distally        with respect to the implant (to allow the longitudinally distal        portion of the implant, typically including the tubular portion        within which valve member 58 is disposed, to expand).

For some applications, delivery tool 89 (e.g., an extracorporeal controlportion 110 thereof, disposed at a proximal portion of the deliverytool) is configured to ensure that the operator follows the particularsequence of movement of capsule-portions 92 and 94 described. Forexample, control portion 110 may comprise a series of locks 114, eachlock becoming unlockable only after the previous step in the sequencehas been completed, the unlocking of the lock allowing the subsequentstep in the sequence to be performed. For some such applications,control portion 110 may further comprise a series of controllers 112,via which the operator causes the movement of a respectivecapsule-portion for each respective step. An example of how controlportion 110 may be used, in accordance with some applications of theinvention, is as follows:

-   -   (1) Operator moves distal capsule-portion 92 distally with        respect to implant 20 by actuating a first controller 112 a.        Once capsule-portion 92 has been moved a given distance, a first        lock 114 a automatically becomes unlockable (and typically        capsule-portion 92 is prevented from moving further than the        given distance).    -   (2) Operator unlocks lock 114 a, and then moves proximal        capsule-portion 94 proximally with respect to implant 20 by        actuating a second controller 112 b. Once capsule-portion 94 has        been moved a given distance, a second lock 114 b automatically        becomes unlockable.    -   (3) Operator unlocks lock 114 b, and then moves distal        capsule-portion 92 further distally with respect to implant 20        by again actuating first controller 112 a. Alternatively,        control portion 110 may comprise a third controller (not shown)        for this second movement of distal capsule-portion 92.

It is to be noted that throughout this patent application (including inthe specification and in the claims) the term “unlockable” means able tobe unlocked (rather than meaning not lockable).

Therefore, apparatus is provided, in accordance with some applicationsof the invention, the apparatus comprising an implant (e.g., implant 20)and a delivery tool (e.g., tool 89), the tool comprising:

(1) a delivery capsule, disposed at a distal portion of the tool, thedelivery capsule comprising a proximal capsule-portion 94 dimensioned tohouse a first part of the implant, and a distal capsule-portion 92dimensioned to house a second part of the implant; and

(2) an extracorporeal control portion 110, disposed at a proximalportion of the tool, the control portion comprising one or morecontrollers 112 and one or more locks 114, the controllers beingoperatively coupled to the proximal and distal capsule-portions suchthat the proximal and distal capsule-portions are movable with respectto the housed implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative suchthat:

-   -   in a first state of the tool:        -   a first distal movement of the distal capsule-portion up to            a first distance distally with respect to the implant is            facilitated,        -   a second distal movement of the distal capsule-portion            further distally with respect to the implant is inhibited,        -   a proximal movement of the proximal capsule-portion            proximally with respect to the implant is inhibited, and        -   responsively to movement of the distal capsule-portion            distally, the tool automatically unlocks a second state of            the tool;    -   in the second state of the tool:        -   the proximal movement of the proximal capsule-portion is            facilitated,        -   the second distal movement of the distal capsule-portion            remains inhibited, and        -   responsively to movement of the proximal capsule-portion            proximally, the tool automatically unlocks a third state of            the tool; and    -   in the third state of the tool:        -   the second distal movement of the distal capsule-portion is            facilitated.

For some applications, rather than having three states, tool 89 has twostates. For clarity, these will be referred to as state A and state B.However, state A may be similar to the second state describedhereinabove, mutatis mutandis. (State A may alternatively be called aprimary state, and state B may alternatively be called a secondarystate.) For applications in which tool 89 has two states, the tooltypically has only one lock 114, the unlocking of which transitions thetool from state A to state B.

In state, A, it is possible to move distal capsule-portion 92 up to thefirst distance distally with respect to implant 20 (e.g., by actuatingcontroller 112 a), and to move proximal capsule-portion 94 proximallywith respect to the implant (e.g., by actuating controller 112 b), butit is not possible to move the distal capsule-portion further distally,which would deploy downstream region 33. Typically, in state A, it isalso possible to return proximal capsule-portion 94 distally and distalcapsule-portion 92 proximally. In state B, it is possible to move distalcapsule-portion 92 further distally, thereby deploying downstream region33. For some applications, lock 114 is not unlockable until distalcapsule-portion 92 has been moved the first distance distally, and/oruntil proximal capsule-portion 94 has been moved proximally.

Therefore, apparatus is provided, in accordance with some applicationsof the invention, the apparatus comprising an implant and a deliverytool, the tool comprising:

-   -   a delivery capsule, disposed at a distal portion of the tool,        the delivery capsule comprising a proximal capsule-portion        dimensioned to house a first part of the implant, and a distal        capsule-portion dimensioned to house a second part of the        implant; and    -   an extracorporeal control portion, disposed at a proximal        portion of the tool, the control portion comprising one or more        controllers and one or more locks, the controllers being        operatively coupled to the proximal and distal capsule-portions        such that the proximal and distal capsule-portions are movable        with respect to the implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative suchthat:

-   -   in a state A of the tool: (i) a first distal movement of the        distal capsule-portion up to a first distance distally with        respect to the implant is facilitated, (ii) a second distal        movement of the distal capsule-portion further distally with        respect to the implant is inhibited, and (iii) a proximal        movement of the proximal capsule-portion proximally with respect        to the implant is facilitated; and    -   in a state B of the tool, the second distal movement of the        distal capsule-portion is facilitated.

As shown in FIG. 1A, for some applications, in the expanded state offrame assembly 22, implant 20 defines a toroidal space 49 betweenflanges 54 and upstream support portion 40 (e.g., a space that is widerthan distance d4). For example, space 49 may have a generally triangularcross-section. It is hypothesized that for some such applications, inaddition to sandwiching tissue of the native valve between upstreamsupport portion 40 and flanges 54 (e.g., the tips of the flanges), space49 advantageously promotes tissue growth therewithin (e.g., betweenleaflet tissue and covering 23), which over time further secures implant20 within the native valve.

Reference is now made to FIG. 5 , which is a schematic illustration of astep in the implantation of implant 20, in accordance with someapplications of the invention. Whereas FIGS. 4A-F show an implantationtechnique in which flanges 54 are expanded prior to upstream supportportion 40, for some applications the upstream support portion isexpanded prior to the flanges. FIG. 5 shows a step in such anapplication.

Reference is again made to FIGS. 2A-5 . As noted hereinabove, implant 20may be implanted by causing flanges 54 to radially protrude beforecausing upstream support portion 40 to radially protrude, or may beimplanted by causing the upstream support portion to protrude beforecausing the flanges to protrude. For some applications, implant 20 isthereby configured to be deliverable in a downstream direction (e.g.,transseptally, as shown, or transapically) or in an upstream direction(e.g., transapically or via the aortic valve). Thus, for someapplications, an operating physician may decide which delivery route ispreferable for a given application (e.g., for a given subject, and/orbased on available equipment and/or expertise), and implant 20 isresponsively prepared for the chosen delivery route (e.g., by loadingthe implant into an appropriate delivery tool).

It is to be noted that for some applications, downstream delivery ofimplant 20 may be performed by expanding flanges 54 first (e.g., asshown in FIGS. 4A-F) or by expanding upstream support portion 40 first(e.g., as shown in FIG. 5 ). Similarly, for some applications upstreamdelivery of implant 20 may be performed by upstream support portion 40first, or by expanding flanges 54 first.

Reference is now made to FIG. 6 , which is a schematic illustration ofimplant 20, in the state and position shown in FIG. 4D, in accordancewith some applications of the invention. For some applications, whileimplant 20 is in the state and position shown in FIG. 4D, leaflets 12 ofvalve 10 are able to move, at least in part in response to beating ofthe heart. Frame (A) shows leaflets 12 during ventricular systole, andframe (B) shows the leaflets during ventricular diastole. For some suchapplications, blood is thereby able to flow from atrium 6 to ventricle8, between leaflets 12 and implant 20. It is hypothesized that thisadvantageously facilitates a more relaxed implantation procedure, e.g.,facilitating retaining of implant 20 in this state and position for aduration of greater than 8 minutes. During this time, imaging techniquesmay be used to verify the position of implant 20, and/or positioning ofleaflets 12 between upstream support portion 40 and flanges 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematicillustrations of frame assemblies 122 and 222 of respective implants, inaccordance with some applications of the invention. Except where notedotherwise, frame assemblies 122 and 222 are typically identical to frameassembly 22, mutatis mutandis. Elements of frame assemblies 122 and 222share the name of corresponding elements of frame assembly 22.Additionally, except where noted otherwise, the implants to which frameassemblies 122 and 222 belong are similar to implant 20, mutatismutandis.

Frame assembly 122 comprises (i) a valve frame 130 that comprises atubular portion 132 and an upstream support portion 140 that typicallycomprises a plurality of arms 146, and (ii) an outer frame (e.g., a legframe) 160 that circumscribes the valve frame, and comprises a pluralityof legs 150 that each comprise a tissue-engaging flange 154. Typically,outer frame 160 comprises a ring 166 to which legs 150 are coupled. Ring166 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 130 at respective coupling points 152, e.g., asdescribed hereinabove for frame assembly 22, mutatis mutandis.

Frame assembly 222 comprises (i) a valve frame 230 that comprises atubular portion 232 and an upstream support portion 240 that typicallycomprises a plurality of arms 246, and (ii) an outer frame (e.g., a legframe) 260 that circumscribes the valve frame, and comprises a pluralityof legs 250 that each comprise a tissue-engaging flange 254. Typically,outer frame 260 comprises a ring 266 to which legs 250 are coupled. Ring266 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 230 at respective coupling points 252, e.g., asdescribed hereinabove for frame assembly 22, mutatis mutandis.

Whereas arms 46 of frame assembly 22 are shown as extending fromupstream end 34 of tubular portion 32, arms 146 and 246 of frameassemblies 122 and 222, respectively, extend from sites furtherdownstream. (This difference may also be made to frame assembly 22,mutatis mutandis.) Tubular portions 32, 132 and 232 are each defined bya repeating pattern of cells that extends around the centrallongitudinal axis. Typically, and as shown, tubular portions 32, 132 and232 are each defined by two stacked, tessellating rows of cells. In theexpanded state of each tubular portion, these cells are typicallynarrower at their upstream and downstream extremities than midwaybetween these extremities. For example, and as shown, the cells may beroughly diamond or astroid in shape. In frame assembly 22, each arm 46is attached to and extends from a site 35 that is at the upstreamextremity of cells of the upstream row. In contrast, in frame assemblies122 and 222, each arm 146 or 246 is attached to and extends from a site135 (assembly 122) or 235 (assembly 222) that is at the connectionbetween two adjacent cells of the upstream row (alternatively describedas being at the upstream extremity of cells of the downstream row).

It is hypothesized by the inventors that this lower position of thearms, while maintaining the length of the lumen of the tubular portion,advantageously reduces the distance that the tubular portion (i.e., thedownstream end thereof) extends into the ventricle of the subject, andthereby reduces a likelihood of inhibiting blood flow out of theventricle through the left ventricular outflow tract. It is furtherhypothesized that this position of the arms reduces radial compressionof the tubular portion by movement of the heart, due to greater rigidityof the tubular portion at sites 135 and 235 (which is supported by twoadjacent cells) than at site 35 (which is supported by only one cell).

As shown, in the expanded state of frame assemblies 22, 122 and 222, thelegs (50, 150 and 250, respectively) are circumferentially staggeredwith the arms of the upstream support portion (46, 146 and 246,respectively). This allows the legs to move in an upstream directionbetween the arms during expansion of the tubular portion (32, 132 and232, respectively), facilitating application of greater sandwichingforce on tissue of the native valve. The lower position of the arms ofassemblies 122 and 222 includes circumferentially shifting the positionof the arms by the width of half a cell. In order to maintain thecircumferential staggering of the arms and legs, rings 166 and 266 (andthereby legs 150 and 250) are circumferentially shifted correspondingly.As a result, whereas the peaks of ring 66 generally align withconnections between adjacent cells of the downstream row of cells oftubular portion 32 (and are fixed to these sites), the peaks of rings166 and 266 are generally aligned midway between these sites (i.e., atspaces of the cellular structure of the tubular portion). Appendages 168(for assembly 122) or 268 (for assembly 222) facilitate fixing of thepeak with respect to the tubular structure.

For assembly 122, appendages 168 are defined by valve frame 130 (e.g.,by tubular portion 132 thereof) and extend (in a downstream direction)to the peaks of ring 166, to which they are fixed. For example, eachappendage 168 may define a valve-frame coupling element 131 that isfixed to a respective outer-frame coupling element 161 defined by outerframe 260. Typically, appendages 168 extend from sites 135. Typically,appendages 168 are integral with tubular portion 132 and/or in-planewith the tubular portion (e.g., are part of its tubular shape).

For assembly 222, appendages 268 are defined by outer frame 260, andextend (e.g., in an upstream direction) from the peaks of ring 266.Typically, appendages 268 extend to sites 235, to which they are fixed.For example, each appendage 268 may define an outer-frame couplingelement 261 that is fixed to a respective valve-frame coupling element231 defined by valve frame 230 (e.g., by tubular portion 232 thereof).Typically, appendages 268 are integral with outer frame 260 and/orin-plane with adjacent portions of outer frame 260, such as ring 266.

Therefore, frame assembly 122 defines a hub at site 135, and frameassembly 222 defines a hub at site 235. For some applications, apparatustherefore comprises:

-   -   a plurality of prosthetic valve leaflets; and    -   a frame assembly, comprising:        -   a tubular portion (132 or 232) defined by a repeating            pattern of cells, the tubular portion extending            circumferentially around longitudinal axis ax1 so as to            define a longitudinal lumen, the prosthetic valve leaflets            coupled to the inner frame and disposed within the lumen;        -   an outer frame (160 or 260), comprising a plurality of legs            (150 or 250), distributed circumferentially around the            tubular portion, each leg having a tissue-engaging flange            (154 or 254);        -   an upstream support portion (140 or 240) that comprises a            plurality of arms (146 or 246) that extend radially outward            from the tubular portion; and        -   a plurality of appendages (168 or 268), each having a first            end that defines a coupling element (161 or 261) via which            the tubular portion is coupled to the outer frame, and a            second end;

wherein the frame assembly defines a plurality of hubs (135 or 235),distributed circumferentially around the longitudinal axis on a planethat is transverse to longitudinal axis ax1, each hub defined byconvergence and connection of, (i) two adjacent cells of the tubularportion, (ii) an arm of the plurality of arms, and (iii) an appendage ofthe plurality of appendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of animplant 320 comprising a frame assembly 322, in accordance with someapplications of the invention. Except where noted otherwise, frameassembly 322 is identical to frame assembly 122, and implant 300 isidentical to the implant to which frame assembly 122 belongs, mutatismutandis. FIG. 9A is a side-view of implant 320, and FIG. 9B is anisometric bottom-view of the implant.

Frame assembly 122 comprises (i) a valve frame 330 that comprises atubular portion 332 and an upstream support portion 340 that typicallycomprises a plurality of arms 346, and (ii) an outer frame (e.g., a legframe) 360 that circumscribes the valve frame, and comprises a pluralityof legs 350 that each comprise a tissue-engaging flange 354. Typically,outer frame 360 comprises a ring 366 to which legs 350 are coupled. Ring366 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 330 at respective coupling points 352, e.g., asdescribed hereinabove for frame assembly 22 and/or frame assembly 122,mutatis mutandis.

Frame assembly 322 comprises an annular upstream support portion 340that has an inner portion 342 that extends radially outward from theupstream portion (e.g., the upstream end) of tubular portion 332.Upstream support portion 340 further comprises one or more fabricpockets 344 disposed circumferentially around inner portion 342, eachpocket of the one or more pockets having an opening that faces adownstream direction (i.e., generally toward the downstream end ofimplant 320). In the figures, upstream support portion 340 has a singletoroidal pocket 344 that extends circumferentially around inner portion342.

Typically, a covering 323 (e.g., similar to covering 23, describedhereinabove, mutatis mutandis) is disposed over arms 346, therebyforming pocket 344. Further typically, arms 346 are shaped to formpocket 344 from covering 323. For example, and as shown, arms 346 maycurve to form a hook-shape.

For some applications, portion 340 has a plurality of separate pockets344, e.g., separated at arms 346. For some such applications, covering323 is loosely-fitted (e.g., baggy) between radially-outward parts ofarms 346, e.g., compared to inner portion 342, in which the covering ismore closely-fitted between radially-inward parts of the arms.

FIG. 9C shows implant 320 implanted at native valve 10. Pocket 344 istypically shaped and arranged to billow in response to perivalvular flow302 of blood in an upstream direction. If ventricular systole forcesblood in ventricle 8 between implant 320 and native valve 10, that bloodinflates pocket 344 and presses it (e.g., covering 323 and/or theradially-outward part of arm 346) against tissue of atrium 6 (e.g.,against the atrial wall), thereby increasing sealing responsively. It ishypothesized by the inventors that the shape and orientation of pocket344 (e.g., the hook-shape of arms 346) facilitates this pressingradially-outward in response to the pocket's receipt of upstream-flowingblood.

Pocket(s) 344 may be used in combination with any of the implantsdescribed herein, mutatis mutandis.

Reference is again made to FIGS. 1A-9C. It is to be noted that unlessspecifically stated otherwise, the term “radially outward” (e.g., usedto describe upstream support portion 40 and flanges 54) means portionsof the element are disposed progressively further outward from a centralpoint (such as longitudinal axis ax1 or tubular portion 32), but doesnot necessarily mean disposed at 90 degrees with respect to longitudinalaxis ax1. For example, flanges 54 may extend radially outward at 90degrees with respect to longitudinal axis ax1, but may alternativelyextend radially outward at a shallower angle with respect to thelongitudinal axis.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A method, comprising: percutaneouslyadvancing an implant to a native heart valve of a subject, the implanthoused in a compressed state within a delivery tool; unhousing alongitudinally-intermediate portion of the implant, thelongitudinally-intermediate portion being longitudinally between alongitudinally-proximal portion of the implant and a longitudinallydistal portion of the implant; subsequently, unhousing thelongitudinally-proximal portion of the implant; and subsequently,unhousing the longitudinally-distal portion of the implant, wherein:unhousing the longitudinally-intermediate portion of the implantcomprises unhousing flanges of the implant such that the flangesautomatically expand, and such that upon the flanges expanding aproximal end of each flange extends radially outward from a centrallongitudinal axis of the implant and longitudinally in a proximaldirection.
 2. The method according to claim 1, wherein: unhousing thelongitudinally-proximal portion of the implant comprises unhousing anupstream support portion of the implant such that the upstream supportportion automatically expands; and unhousing the longitudinally-distalportion of the implant comprises unhousing the longitudinally-distalportion of the implant such that the longitudinally-distal portion ofthe implant automatically expands.
 3. The method according to claim 2,wherein the longitudinally-distal portion includes a tubular portionwithin which a valve member is disposed, and wherein unhousing thelongitudinally-distal portion of the implant comprises unhousing thelongitudinally-distal portion of the implant such that the tubularportion expands to form a lumen and the valve member regulates one-wayflow of blood through the lumen.
 4. The method according to claim 3,wherein unhousing the longitudinally-distal portion of the implantcomprises facilitating expansion of the implant such that the tubularportion expands and the flanges become longitudinally closer to theupstream support portion.
 5. The method according to claim 4, whereinfacilitating expansion of the implant comprises sandwiching leaflets ofthe native heart valve between the flanges and the upstream supportportion.
 6. The method according to claim 1, wherein: percutaneouslyadvancing the implant to the native heart valve comprises advancing theimplant housed within a capsule of the delivery tool, the capsule havinga distal capsule-portion and a proximal capsule-portion, unhousing thelongitudinally-intermediate portion of the implant comprises unhousingthe longitudinally-intermediate portion from within the distalcapsule-portion by moving the distal capsule-portion distally withrespect to the implant, unhousing the longitudinally-proximal portioncomprises unhousing the longitudinally-proximal portion from within theproximal capsule-portion by moving the proximal capsule-portionproximally with respect to the implant, and unhousing thelongitudinally-distal portion of the implant comprises deploying thelongitudinally-distal portion of the implant from the distalcapsule-portion.
 7. The method according to claim 6, wherein deployingthe longitudinally-distal portion of the implant from the distalcapsule-portion comprises additionally moving the distal capsule-portiondistally with respect to the implant.
 8. Apparatus, comprising: animplant for implantation at a native valve of a heart of a subject, theimplant comprising a valve frame assembly comprising: a tubular portionhaving an upstream end and a downstream end that defines, in part, alongitudinally-distal portion of the implant; an upstream supportportion, extending from the upstream end of the tubular portion, theupstream portion defining a longitudinally-proximal portion of theimplant; and a plurality of tissue-engaging flanges coupled to thetubular portion at respective coupling points, the plurality of flangesdefining a longitudinally-intermediate portion of the implant; and adelivery tool: comprising a delivery capsule dimensioned (i) to houseand retain the implant in a compressed state of the implant in which (a)the tubular portion is in a constrained-tubular-portion state, (b) theupstream support portion is in a constrained-upstream-support-portionstate, and (c) the plurality of flanges are in a constrained-flangestate, and (ii) to be advanced percutaneously to the heart of thesubject while the implant is housed and in the compressed state, andoperable from outside the subject to: transition the implant from thecompressed state into an intermediate state of the implant by (1)unhousing the longitudinally-intermediate portion, while retaining thetubular portion in the constrained-tubular-portion state, and (2)subsequently, unhousing the longitudinally-proximal portion of theimplant, while retaining at least the longitudinally-distal portion ofthe implant in a constrained state, and subsequently, unhouse thelongitudinally-distal portion of the implant such that the implantassumes an expanded state, such that in the expanded state a proximalend of each flange extends radially outward from a central longitudinalaxis of the implant and longitudinally in a proximal direction.
 9. Theapparatus according to claim 8, wherein: the upstream support portion isconfigured such that, upon the implant entering the intermediate state,the upstream support portion is expanded into areleased-upstream-support-portion state.
 10. The apparatus according toclaim 8, wherein the tubular portion is configured such that, upon theimplant transitioning from the intermediate state to the expanded state,the tubular portion expands and thereby moves the plurality of flangeslongitudinally closer to the upstream support portion.
 11. The apparatusaccording to claim 8, wherein the tubular member comprises a valvemember, and wherein, in the expanded state of the implant, the tubularportion defines a lumen therethrough, and the valve member is configuredto regulate one-way flow of blood through the lumen.
 12. The apparatusaccording to claim 8, wherein the capsule of the delivery tool comprisesa distal capsule-portion and a proximal capsule-portion, and wherein thecapsule is configured such that: upon the implant entering theintermediate state, (i) the distal capsule-portion is moved distallywith respect to the implant to unhouse the longitudinally-intermediateportion of the implant, while still surrounding thelongitudinally-distal portion of the implant, and (ii) the proximalcapsule-portion is moved proximally with respect to the implant tounhouse the longitudinally-proximal portion, and upon the implantentering the expanded state, the distal capsule-portion is moved furtherdistally with respect to the implant to unhouse thelongitudinally-distal portion of the implant.
 13. A method, comprising:percutaneously advancing an implant to a native heart valve of asubject, the implant housed in a compressed state within a deliverytool; unhousing a longitudinally-intermediate portion of the implant,the longitudinally-intermediate portion being longitudinally between alongitudinally-proximal portion of the implant and a longitudinallydistal portion of the implant; subsequently, unhousing thelongitudinally-proximal portion of the implant; and subsequently,unhousing the longitudinally-distal portion of the implant, wherein:unhousing the longitudinally-intermediate portion of the implantcomprises unhousing flanges of the implant such that the flangesautomatically expand; unhousing the longitudinally-proximal portion ofthe implant comprises unhousing an upstream support portion of theimplant such that the upstream support portion automatically expands;and unhousing the longitudinally-distal portion of the implant comprisesunhousing the longitudinally-distal portion of the implant such that thelongitudinally-distal portion of the implant automatically expands,wherein the longitudinally-distal portion includes a tubular portionwithin which a valve member is disposed, and wherein unhousing thelongitudinally-distal portion of the implant comprises unhousing thelongitudinally-distal portion of the implant such that the tubularportion expands to form a lumen and the valve member regulates one-wayflow of blood through the lumen, and wherein unhousing thelongitudinally-distal portion of the implant comprises facilitatingexpansion of the implant such that the tubular portion expands and theflanges become longitudinally closer to the upstream support portion.14. A method, comprising: percutaneously advancing an implant to anative heart valve of a subject, the implant housed in a compressedstate within a delivery tool; unhousing a longitudinally-intermediateportion of the implant, the longitudinally-intermediate portion beinglongitudinally between a longitudinally-proximal portion of the implantand a longitudinally distal portion of the implant; subsequently,unhousing the longitudinally-proximal portion of the implant; andsubsequently, unhousing the longitudinally-distal portion of theimplant, wherein: percutaneously advancing the implant to the nativeheart valve comprises advancing the implant housed within a capsule ofthe delivery tool, the capsule having a distal capsule-portion and aproximal capsule-portion, unhousing the longitudinally-intermediateportion of the implant comprises unhousing thelongitudinally-intermediate portion from within the distalcapsule-portion by moving the distal capsule-portion distally withrespect to the implant, unhousing the longitudinally-proximal portioncomprises unhousing the longitudinally-proximal portion from within theproximal capsule-portion by moving the proximal capsule-portionproximally with respect to the implant, and unhousing thelongitudinally-distal portion of the implant comprises deploying thelongitudinally-distal portion of the implant from the distalcapsule-portion.
 15. The method according to claim 14, wherein deployingthe longitudinally-distal portion of the implant from the distalcapsule-portion comprises additionally moving the distal capsule-portiondistally with respect to the implant.
 16. Apparatus, comprising: animplant for implantation at a native valve of a heart of a subject, theimplant comprising a valve frame assembly comprising: a tubular portionhaving an upstream end and a downstream end that defines, in part, alongitudinally-distal portion of the implant; an upstream supportportion, extending from the upstream end of the tubular portion, theupstream portion defining a longitudinally-proximal portion of theimplant; and a plurality of tissue-engaging flanges coupled to thetubular portion at respective coupling points, the plurality of flangesdefining a longitudinally-intermediate portion of the implant; and adelivery tool: comprising a delivery capsule dimensioned (i) to houseand retain the implant in a compressed state of the implant in which (a)the tubular portion is in a constrained-tubular-portion state, (b) theupstream support portion is in a constrained-upstream-support-portionstate, and (c) the plurality of flanges are in a constrained-flangestate, and (ii) to be advanced percutaneously to the heart of thesubject while the implant is housed and in the compressed state, andoperable from outside the subject to: transition the implant from thecompressed state into an intermediate state of the implant by (1)unhousing the longitudinally-intermediate portion, while retaining thetubular portion in the constrained-tubular-portion state, and (2)subsequently, unhousing the longitudinally-proximal portion of theimplant, while retaining at least the longitudinally-distal portion ofthe implant in a constrained state, and subsequently, unhouse thelongitudinally-distal portion of the implant such that the implantassumes an expanded state, wherein the tubular portion is configuredsuch that, upon the implant transitioning from the intermediate state tothe expanded state, the tubular portion expands and thereby moves theplurality of flanges longitudinally closer to the upstream supportportion.
 17. Apparatus, comprising: an implant for implantation at anative valve of a heart of a subject, the implant comprising a valveframe assembly comprising: a tubular portion having an upstream end anda downstream end that defines, in part, a longitudinally-distal portionof the implant; an upstream support portion, extending from the upstreamend of the tubular portion, the upstream portion defining alongitudinally-proximal portion of the implant; and a plurality oftissue-engaging flanges coupled to the tubular portion at respectivecoupling points, the plurality of flanges defining alongitudinally-intermediate portion of the implant; and a delivery tool:comprising a delivery capsule dimensioned (i) to house and retain theimplant in a compressed state of the implant in which (a) the tubularportion is in a constrained-tubular-portion state, (b) the upstreamsupport portion is in a constrained-upstream-support-portion state, and(c) the plurality of flanges are in a constrained-flange state, and (ii)to be advanced percutaneously to the heart of the subject while theimplant is housed and in the compressed state, and operable from outsidethe subject to: transition the implant from the compressed state into anintermediate state of the implant by (1) unhousing thelongitudinally-intermediate portion, while retaining the tubular portionin the constrained-tubular-portion state, and (2) subsequently,unhousing the longitudinally-proximal portion of the implant, whileretaining at least the longitudinally-distal portion of the implant in aconstrained state, and subsequently, unhouse the longitudinally-distalportion of the implant such that the implant assumes an expanded state,wherein the capsule of the delivery tool comprises a distalcapsule-portion and a proximal capsule-portion, and wherein the capsuleis configured such that: upon the implant entering the intermediatestate, (i) the distal capsule-portion is moved distally with respect tothe implant to unhouse the longitudinally-intermediate portion of theimplant, while still surrounding the longitudinally-distal portion ofthe implant, and (ii) the proximal capsule-portion is moved proximallywith respect to the implant to unhouse the longitudinally-proximalportion, and upon the implant entering the expanded state, the distalcapsule-portion is moved further distally with respect to the implant tounhouse the longitudinally-distal portion of the implant.